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Meeting the Requirements of the
1998 Minnesota Food Code
Minnesota Department of Agriculture, Dairy and Food Inspection Division
625 Robert St. N., St. Paul, MN 55155-2538 • 651-201-6027
Table of Contents
Section 1 - Introduction to Food Safety Systems
About HACCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
HACCP Requirements in the Minnesota Food Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Introduction to the Preliminary Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
Introduction to the 7 HACCP Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Section 2 - The Preliminary Steps
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Step 1 - Assemble the HACCP Team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Step 2 - Identify Products/Processes to be Covered. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Step 3 - Develop a Complete List of Ingredients, Materials, Equipment
and Recipes/Formulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Steps 4 and 5 - Develop and Verify a Process Flow Diagram . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10
Section 3 - Utilizing the 7 Principles of HACCP
Understanding Hazards and Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Principle 1 - Conduct a Hazard Analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Principle 2 - Identify Critical Control Points . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Principle 3 - Establish Critical Limits for Each Control Point . . . . . . . . . . . . . . . . . . . . . . . 3-20
Principle 4 - Establish Monitoring Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
Principle 5 - Establish Corrective Actions - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Principle 6 - Establish Record Keeping Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Principle 7 - Establish Verification Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Section 4 - MN Food Code Requirements
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Contents of a HACCP Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Compliance with the HACCP Plan. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Variances and the HACCP Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Reduced Oxygen Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Section 5 Sample HACCP Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Appendix
Uniform Minnesota Food Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Common Foodborne Bacterial Pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Sample Plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv
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1
Section
Introduction to Food
Safety Systems
About HACCP
What is HACCP?
The Hazard Analysis Critical Control Point system is a preventative system for assuring the safe production
of food products. It is based on a common sense application of technical and scientific principles to a food
production process.
The most basic concept underlying HACCP is that of prevention. The food processor/handler should have
sufficient information concerning the food and the related procedures they are using, so they will be able to
identify where a food safety problem may occur and how it will occur. If the ‘where’ and ‘how’ are known,
prevention becomes easy and obvious, and finished product inspection and testing becomes needless. The
HACCP program deals with control of factors affecting the ingredients, product and process. The objective
is to make the product safely, and be able to prove that the product has been made safely. The where and
how are the HA (Hazard Analysis) part of HACCP. The proof of the control of the processes and conditions
is the CCP (Critical Control Point) part. Flowing from this basic concept, HACCP is simply a methodical
and systematic application of the appropriate science and technology to plan, control and document the safe
production of foods.
HACCP is not the only method in ensuring that safe food products are manufactured. The plan will be
successful when other procedures are in place such as sanitation standard operating procedures (SSOP’s) and
by using good manufacturing practices (GMP’s). Although the Minnesota Food Code does not require them,
these programs are fundamental in the development of a successful HACCP plan. SSOP’s should include
personal hygiene practices as well as daily sanitation of the food contact surfaces and equipment. Good
sanitation practices are the foundation of manufacturing and preparing safe food.
HACCP is a management system in which food safety is addressed through the analysis and control of
biological, chemical, and physical hazards from raw material production, procurement and handling, to
manufacturing, distribution, and consumption of the finished product. For successful implementation of an
HACCP plan, management must be strongly committed to the HACCP concept. A firm committed to HACCP
by top management, provides company employees with the sense of importance of producing safe food.
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HACCP Requirements in the Minnesota Food Code
The Minnesota Food Code is the state rule that governs retail food
establishments. With the adoption of the Minnesota Food Code in September
1998, retail food establishments that conduct certain food processes or
operations are required to operate under a HACCP plan.
Processes or operations that require HACCP:
1. Smoking or curing food, except for smoking done for the purpose of imparting flavor only, and
not as a part of the part of the cooking process.
2. Using food additives or adding components, including vinegar, as a method to preserve food
(rather than to enhance its flavor) or change food into a non-potentially hazardous food.
3. Using a reduced oxygen method of packaging food.
4. Food Establishments that apply for a variance to:
- use more than one tagged shellstock container at a
time.
- deviate from required cooking times and
temperatures for raw animal foods.
- use molluscan shellfish life support system
display tanks to store and display shellfish that
are offered for sale.
Timing/Effective Dates
After January 26, 2000 existing food establishments with these operations must have that plan available
on site for review.
After July 1, 1999, new or extensively remodeled food establishments with these operations must submit
a HACCP plan for approval as part of the plan review.
Additional MN Food Code Requirements
While the process of developing a HACCP plan is a rather universal one, the Minnesota Food Code
requires some additional components that need to be included as part of the firms HACCP plan.
Section 4 provides details on the additional requirements such as standard operating procedures, duties
of the person in charge. HACCP plans that cover reduced oxygen packaging operations, must include
several additional pieces of information.
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Definitions:
CP Decision Tree: A sequence of questions to assist
in determining whether a control point is a CCP.
HACCP System: The result of the implementation of
the HACCP Plan procedures to be followed.
Continuous Monitoring: Uninterrupted collection
and recording of data such as temperature
on a stripchart, or a continuous recording
thermometer.
HACCP Team: The group of people who are
responsible for developing, implementing and
maintaining the HACCP system.
Control: (a) To manage the conditions of an
operation to maintain compliance with
established criteria. (b) The state where correct
procedures are being followed and criteria are
being met.
Control Measure: Any action or activity that can be
used to prevent, eliminate or reduce a significant
hazard.
Control Point: Any step at which biological,
chemical, or physical factors can be controlled.
Corrective Action: Procedures followed when a
deviation occurs.
Criterion: A requirement on which a judgment or
decision can be based.
Hazard Analysis: The process of collecting and
evaluating information on hazards associated
with the food under consideration to decide
which are significant and must be addressed in
the HACCP plan.
Monitor: To conduct a planned sequence of
observations or measurements to assess whether
a CCP is under control and to produce an
accurate record for future use in verification.
Prerequisite Programs: Procedures, including
Good Manufacturing Practices, that address
operational conditions providing the foundation
for the HACCP system.
Critical Control Point (CCP): A point, step or
procedure at which control can be applied and
is essential to prevent or eliminate a food safety
hazard, or reduce it to an acceptable level.
Preventative Measure: Physical, chemical, or other
factors that can be used to control an identified
health hazard.
Critical Defect: A deviation at a CCP which may
result in a hazard.
Sensitive Ingredient: An ingredient known to have
been associated with a hazard for which there is
a reason for concern.
Critical Limit: A maximum and/or minimum value
to which a biological, chemical or physical
parameter must be controlled at a CCP to
prevent, eliminate or reduce to an acceptable
level the occurrence of a food safety hazard.
Deviation: Failure to meet a critical limit.
Food Code: Minnesota Rules 4626
HACCP: A systematic approach to identification,
evaluation, and control of food safety hazards.
HACCP Plan: The written document which is
based upon the principles of HACCP and
which delineates the procedures to be followed
to assure the control of specific process or
procedure.
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Hazard: A biological, chemical, or physical agent
that is reasonably likely to cause a food to be
unsafe for consumption.
Severity: The seriousness of the effect(s) of a hazard.
Step: A point, procedure, operation or stage in the
food system from primarily production to final
consumption.
Validation: That element of verification focused on
collecting and evaluating scientific and technical
information to determine if the HACCP plan,
when properly implemented, will effectively
control the hazards.
Verification: Those activities such as methods,
procedures, or tests in addition to monitoring,
that determines if the HACCP system is in
compliance with the HACCP plan and/or
whether the HACCP plan needs modification and
revalidation.
An Introduction to Preliminary Steps
The development of a HACCP plan is a logical step-by-step process. Each step builds on the information gathered
from the previous step. The process works better if you take some preliminary steps. You may wish to use the
example forms located in Section 5 or you may want to create your own forms.
1.
Assemble the HACCP Team
The first thing that must be done is to bring together individuals in your facility who have a working
knowledge of the various processing steps and operations in your facility. This group will be your
“HACCP team.” It is understood that in some smaller establishments, the ‘team’ may be very small and
may even consist of one person - the owner/operator.
2.
Identify Products/Foods/Processes that must be covered by the HACCP plan
Next, the HACCP team should write a categorization of the types of potentially hazardous foods that
are covered. Foods and processes with similar characteristics can be grouped together.
3.
Develop a List of Ingredients, materials, equipment and recipes/formulations.
The third step is for the team to thoroughly review each product and write down all of the ingredients,
materials, and equipment used in the preparation of a food and also to write down formulations or
recipes that show methods and control measures that address the food safety concerns involved.
4.
Develop a Process Flow Diagram
At the fourth step, the HACCP team will draw a flow diagram that shows all the steps in the production
process (everything from receiving through distribution.)
5.
Verify the Process Flow Diagram
The final step is to take this flow diagram and verify its accuracy. The HACCP team can do this by
having an impartial person do a “walk-through” of the entire production process, checking to see
if there is anything missing from the diagram. This should be done by someone who knows, or is
familiar with the production process.
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An Introduction to the 7 HACCP Steps
Principle 1: Conduct a Hazard Analysis
The hazard analysis looks at different factors that could affect the safety of your product. This analysis is
done for each step in your production process. It’s important to remember that you are dealing with safety, not
quality issues.
The hazard analysis is actually completed in two stages. The first stage identifies food safety hazards that
are present in your process. The second stage evaluates these food safety hazards as to whether they are
“reasonably likely to occur.” If the HACCP team decides that a food safety hazard is likely to occur, then
they need to find and list any preventive measures that could be used to control those food safety hazards.
Preventive measures are defined as: “Physical, chemical, or other means that can be used to control an
identified food safety hazard.”
INGREDIENT RELATED HAZARDS: As you evaluate the hazards in your process, don’t forget about
ingredient related hazards. Everything that goes into your product needs to be evaluated. Ingredient
specifications, provided by your supplier, should give you details on the materials/ingredients being sold,
including statements that the materials/ingredients are of food grade and are free of harmful components.
For example, the ingredient specification for dried legumes (beans) might state that there will be fewer that 5
small rocks or stones per ten pound bag and that no harmful pesticides were used in the growing process.
Principle 2: Identify Critical Control Points (CCP’s)
A critical control point is defined as “A point, step or procedure in a food process at which control can be
applied and, as a result, a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
The HACCP team uses the list of food safety hazards and preventative measures they developed during the
previous hazard analysis step to determine their critical control points. CCP’s may include, but are not limited to:
• Chilling or freezing
• Cooking
• Certain processing procedures; smoking, curing, acidification
Steps that are CCP’s in one facility may or may not be CCP’s in your facility. When making a HACCP plan,
each facility must look at the unique conditions present in that facility.
Principle 3: Establish Critical Limits for Each CCP
A critical limit is defined as “The maximum or minimum value to which a physical, biological, or chemical
hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the
occurrence of the identified food safety hazard.” Critical limits serve as boundaries of safety for each CCP.
Often they are a numerical value (whether that is temperature, pH, etc.) that must be reached to assure that a
food safety hazard has been controlled.
[ A note about Critical Limits -- When your HACCP team establishes critical limits for your specific facility,
know that those limits may never be less strict than the current regulatory standards.]
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Principle 4:
Establish CCP Monitoring Procedures
Monitoring Requires Precision
Monitoring is a fundamental part of any HACCP system.
It consists of observations or measurements that check to
see that your CCP’s are operating under control.
Monitoring a CCP is a big responsibility.
Employees must be properly trained and need
to understand the reasons for careful monitoring
procedures.
Monitoring serves three main purposes:
First,
it tells you when there’s a problem at a CCP, and
control has been temporarily lost. (This allows
you to take corrective actions right away.)
Second,
it tracks the system’s operation and can help
identify dangerous trends that could lead to a loss
of control. (This allows you to take preventive
action to bring the process back into control before
it goes beyond the critical limits.)
Third,
it provides written documentation of your
compliance with the HACCP regulation. (This
information can be used to confirm that your
HACCP plan is in place and working right.)
Specify in your monitoring procedures, every
important detail about...
• Who will do the monitoring
• What is being monitored
• When it is done, and
• How it is done
For example, when taking the temperature
of a piece of meat, be specific as to where
you took the temperature. Remember that
all records and documents associated with a
CCP’s monitoring should be dated and signed
or initialed by the person doing the monitoring
and the results recorded.
For each CCP the HACCP team will need to define the monitoring procedure and its frequency (hourly, daily,
weekly, etc.) that best tracks that CCP. It’s also important to thoroughly train the employee(s) that will be
responsible for each monitoring procedure and frequency.
Principle 5: Establish Corrective Actions
Corrective actions are defined as “Procedures to be followed when a deviation occurs.” A deviation is defined
as a “failure to meet a critical limit.” Corrective actions are taken when monitoring shows you that a food
safety hazard has gotten out of control at a CCP.
The best way to handle deviations is to have a plan of action already in place. In general, corrective action
plans are used for:
1. Determining the disposition of non-complying product;
2. Correcting the cause of the non-compliance to prevent a reccurrence:
3. Demonstrating that the CCP is once again under control (this means examining the process or product
again at the CCP and getting results that are within the critical limits).
As with the monitoring procedures, specific corrective action procedures must be developed for each CCP.
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Principle 6: Establish Recordkeeping Procedures
Record keeping procedures are important in making and keeping an HACCP system effective. Every time
monitoring procedures are done, corrective actions are taken, or production equipment is serviced, a detailed
record of that activity is made. This continual recording of this information allows you to keep track of
everything that goes on in your facility.
You can think of HACCP records in two ways, development forms and day-to-day “working” logs. The
development forms are all of the supporting documentation that go into building your first HACCP plan. The
“working” logs are the sheets of paper where you collect the details of what happen on the production floor.
You may wish to use the example forms located in Section 5, or you may wish to create your own forms.
Generally, the records kept in the total HACCP system include the following:
• The HACCP plan itself and all supporting documentation.
• Records (including product codes) documenting the day-to-day functioning of the HACCP system
such as daily monitoring logs, deviation/corrective action logs, and verification logs.
Principle 7: Establish Verification Procedures
Every establishment should validate the HACCP plan’s adequacy in controlling the food safety hazards
identified during the hazard analysis, and should verify that the plan is being effectively implemented.
1. Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the
establishment shall conduct activities designed to determine that the HACCP plan is functioning as
intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy
of the CCP’S, critical limits, monitoring and record keeping procedures, and corrective actions set forth in
the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by
the HACCP system, in the context of other validation activities.
2. Ongoing verification activities. Ongoing verification activities include, but are not limited to:
• The calibration of process-monitoring instruments
• Direct observations of monitoring activities and corrective actions; and
• The review of records.
3. Reassessment of the HACCP plan. Every establishment should reassess the adequacy of the HACCP plan
at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP
plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw
materials; product formulation; processing methods or systems; production volume; personnel; packaging:
product distribution systems; or, the intended use or consumers of the finished product. One reassessment
should be performed by an individual trained in HACCP principles. The HACCP plan should be modified
immediately whenever a reassessment reveals that the plan no longer meets the requirements of the Food Code.
4. Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a
hazard analysis has revealed no food safety hazards that are reasonably likely to occur should reassess the
adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food
safety hazard exists. Such changes may include, but are not limited to changes in: raw materials or source
of raw materials; product formulation; processing methods or systems; production volume; packaging;
finished product distribution systems or the intended use or consumers of the finished product.
Verification procedures help make the HACCP plan work correctly.
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Notes
A Note
About
Recordkeeping
“No matter
what type
of record
(development
or log) every
record must be
titled, dated
and signed or
initialed by the
activity. In the
development
process, this
person is
normally the
leader of the
HACCP team
who has been
trained in
HACCP. For
the day-today logs, the
person would be
whomever was
assigned the
responsibility of
the procedure,
such as the
monitoring
person.”
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2
Section
The Preliminary Steps
Introduction
Now that you have a general understanding of HACCP, let’s get down to the specifics. Developing a
HACCP plan starts with the collection of important information. This fact-finding process is called the
Preliminary Steps.
They are:
1. Assemble the HACCP team.
2. Identify Products and Processes
3. Develop a complete list of ingredients, raw materials, equipment, recipes and formulations.
4. Develop a process flow diagram that completely describes your purpose.
5. Verify the process flow diagram.
A Note from the Minnesota Department of Agriculture:
In order to show you how an HACCP plan is put together, we are going to show you examples of filled-out
HACCP development forms. The thought of filling out all these forms can be a bit overwhelming at first,
however, it is a straightforward process. We are going to be using an “Example Facility” to show you what
each one of these forms might look like when completed.
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Step 1:
Assemble the HACCP Team
YOUR FIRST TASK in developing a HACCP plan is to
assemble your HACCP team. The HACCP team consists of
individual(s) who will gather the necessary information for
your HACCP plan.
The HACCP team needs to be aware of the following:
•
Your product/process
•
Any food safety programs you already have
•
Food safety hazards of concern
•
The seven principles of HACCP
In a very small facility, perhaps only one individual is available
to be on the HACCP team. This is perfectly acceptable,
however, you can get help from as many people as you need to
make the team function effectively.
The First Meeting
Who should be there, and what
should we do? Here’s a sample
agenda.
• First, describe your product what it is and where it is going.
• Next, gather a complete list of
ingredients
The HACCP team will begin by collecting scientific data. Remember, the team isn’t limited to internal
resources. If needed, outside expertise is available through the Minnesota Department of Agriculture, state
extension offices, trade or professional associations, consultants, universities and libraries.
However you decide to approach it, your HACCP team is ultimately responsible for building your
HACCP plan.
Working with the “HACCP Team” Form
The Example Facility has six HACCP team members. One of whom is not only the general manager, but is also
the owner. It is important to list all the team members and to state clearly what their HACCP team role is. (As
you might think, filling out this form is realtively simple.) Don’t forget to sign and date the form.
[A note about the forms. As with all HACCP forms and logs, the person who is responsible for an
activity (whether it be drafting the forms, or doing the monitoring) should be the one who signs and dates
the form or log.]
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Step 1
HACCP Team Form
Team Members
Role
Cindy Jones
General Manager
Mary Weston
Quality Control
Mark Baker
Wet Room Supervisor
Susan Smith
Packing Supervisor
Joe Jones
Extension Service
Pam Smith
Local Microbilogist
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
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Step 2:
Identify Products/Processes to be Covered
NEXT, make a complete listing of all the products and processes that must be covered under a HACCP plan.
The foods should be categorized by the types of processes that must be covered. The Minnesota Food Code
requires HACCP plans for certain processes. In addition, the requirements for reduced oxygen packaged foods
limit the types of foods that can be packaged in this manner. Review the Minnesota Food Code Requirements
in the Appendix for more details.
Product/Process Description Form
The following is an example of a format that could be used to list the products covered. This sample lists many types
products and processes for this establishment - a typical store would not likely have all of these processes.
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
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Step 3:
Develop a Complete List of Ingredients,
Materials, Equipment and Recipes/Fomulations
THE THIRD STEP is for the team to thoroughly review each product or process and write down all of the
ingredients, materials and equipment used in the preparation or sale of a food and also to write down formulations
or recipes that show methods and control measures that address the food safety concerns involved.
The ingredients list may be as simple as the recipe format listed below or may be more detailed as shown on the
following page. As you can see on the following examples, ingredients and materials fall into several categories.
If the category does not apply to your product/process, you don’t have to write anything in that space.
[If you use pre-packaged or pre-blended ingredients such as a seasoning mix, you can list it by blend (mix) name
and just staple that products information to the back of your Ingredients Form.]
Be sure a recipe is listed for every product you produce.
Ring Bologna
FULL BATCH
50 lbs pork trim
50 lbs beef trim
nd bologna seasoning
6 lbs (1 full package) of xyz bra
Cure with sodium nitrite
4 oz (1 full package) of Quick
10 lbs. of water
Casings - natural beef casing
cing the product.
Also list procedures for produ
Smokehouse Operations Formulation/Recipe
2-5
Step 3
Ingredients and Raw Materials Form
Fully cooked, Ready-to-eat
Product/Process Name: _______________________________________
Beef Jerky
Product/Examples: ___________________________________________
Meat/Poultry and Byproducts
Nonmeat Food Ingredients
Binders/Extenders
Spices/Flavorings
Restricted Ingredients
Preservatives/Addifiers
___ oz. Garlic
___ oz. Pepper (black)
___ oz. Soy Sauce
___ oz. Sodium Nitrite
Liquid
Packaging Materials
___ lb. Tap Water
Vacuum Plastic Pouch
Assorted Labels
50 lbs. Beef Rounds
Other
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
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An additional requirement is to include a listing of all equipment and materials (such as packaging materials)
used for each product produced or each type of process. This information can be written in list form and be
categorized for the different processes.
Equipment List
General J’s Market
123 XYZ Street
Street Address ______________________________________________________________
Anytown
MN Zip Code ______________
55555
City__________________________________
State_______
Store Name ________________________________________________________________
Smokehouse Operations Equipment List
• Walk-in Cooler: Brand ______________________Size _____________________
Other products/Operations Supported __________________________________
• Grinder:
Brand ____________________Model _____________________
• Mixer:
Brand ____________________Model _____________________
• Stuffer:
Brand ____________________Model ____________________
• Smokehouse:
Brand ____________________Model _____________________
Smoke generator/liquid smoke _________________________________________
• Digital Thermometer __________________________________________________
• Assorted measuring container, hand utensils, lugs, totes, etc. ______________________
________________________________________________________________
Reduced Oxygen Packaging Equipment List
• Slicer:
Brand _________________ Model # _____________________
• Vacuum Packaging Machine _____________________________________________
• Digital Thermometer __________________________________________________
• Assorted knives, tongs, trays, lugs, totes, hand utensils, etc. ______________________
________________________________________________________________
• Vacuum plastic pouch _________________________________________________
• Scale/labeling machine ________________________________________________
2-7
Step 4& 5:
Develop and Verify a Process Flow Diagram
AT STEPS 4 AND 5 the team will create a document that will be used over and over again in the HACCP plan
development process. The HACCP team needs to look closely at the production process and make a flow diagram
that shows all the steps used to prepare the product. You don’t need to include steps that are not directly under
your control, such as distribution.
The flow diagram doesn’t need to be complex. Looking at your facility’s floor plan can help you visualize the
process from receiving to shipping. To find all the food safety hazards in your process you need to know exactly
what steps that product/process goes through.
After the HACCP team has completed the flow diagram, it needs to be checked for accuracy. To do this, walk
through the facility and make sure that the steps listed on the diagram realistically describe what occurs during
the production process. If possible, have someone who didn’t make the flow diagram do the “walk-through.”
Working with the “Process Flow Diagram Development and Verification” Form
The Example Facility divided their flow diagram into three paths. Each of these
paths represents one or more ingredients or raw materials. It made sense to
combine certain categories. They grouped all meat items into “Meat”, all-nonmeat food ingredients such as spices and preservatives into “Other Ingredients”,
which just left “Packaging Materials.” These three categories represent the
three main process routes that occur in their facility.
After the HACCP team completed their drawing, the flow diagram was
checked, signed and dated. In the Example Facility as each step was verified
they placed a check mark. The form must be signed and dated again after it is
checked/reviewed.
2-8
Steps 4 & 5
Process Flow Diagram Development
& Verification Form
Beef Jerky/Heat Treated, Shelf Stable
Product/Process Name__________________________________________
Flow Diagram:
MEAT
OTHER INGREDIENTS
PACKAGING
Receiving
Receiving
Receiving
Storage
Storage
Storage
Slicing
Weighing
Marinating
Mixing
Hanging
Cooking
rework
Cooling
Packaging
Storage
Retail Sales
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
Mary Weston
12/12/98
Verified by: ___________________________
Date ____________
2-9
Conclusion:
The Example Facility has successfully completed the fact-finding part of the HACCP development process. Your
work through the preliminary steps should have produced two tangible pieces of information:
1. A comprehensive list of ingredients and raw materials, and
2. A step-by-step production process breakdown, laid out simply in a flow diagram.
With this information you are now ready to proceed to the next stage: Utilizing the 7 Principles of
HACCP.
2-10
Section
Utilizing the 7 Principles
of HACCP
Understanding Hazards and Controls
This section is about using the seven principles of HACCP. Already you have gathered all of te specific information
about our facilities paroducts and processes. Now you’ll put that information to use. When you have worked
throught the principles of HACCP, you’ll have a complete HACCP plan.
Before we start with the first principal, we need to quickly review two important ideas; Food Safety Hazards and
Preventative Measures. Hazards are defined as any biological, chemical or physical property that is reasonably
lickly to cause food to be unsafe for human consumption.
3-1
Hazards are classified into these three categories:
Biological, Chemical, and Physical.
Biological hazards can be bacteria, parasites, or viruses.
Bacteria, parasites, or viruses that cause illness are
called pathogens. In most cases, pathogens must grow
or multiply in food to certain levels in order to cause
foodborne illness. The following factors can affect the
growth of pathogens:
Nutrients
Bacteria require food and water to carry on their life
processes. Since what you are producing is a food
product, nutrients are going to be available. Equipment
that contains food residue can also be a nutrient source
for bacteria.
Temperatures
Another essential factor that affects the growth of
bacteria is temperature. Growth can occur over a wide
range of temperatures from about 14°F to 194°F, but
individual bacteria have much narrower temperature
ranges for growth.
Time
It’s not just the temperature that’s the problem; it’s the
time at these temperatures that can affect growth of
bacteria. The goal is to minimize the time of exposure
of foods to temperatures where bacteria grow most
quickly.
Moisture
The amount of available moisture in a food is measured
as water activity. When substances like salt and sugar
are added to water is tied up and is less available to
the bacteria. The water activity of some foods is listed
below:
Food
Inhibitors
Foods can contain chemicals that are either natural or
added that restrict or prevent growth of microorganisms.
Salt is a good example of an added chemical that can
inhibit growth of bacteria. Chemical preservatives like
sodium nitrite, sodium benzoate, and calcium propionate
can also inhibit the growth of microorganisms.
pH
pH shows how acid a food is. pH ranges from 0 – 14
with 7 being neutral. Foods with a pH of 4.6 and below
are considered acid foods, like most fruit juices. Foods
with a pH above 4.6 are said to be low acid, like meats
and vegetables. Most bacteria don’t grow very well in
acid foods, so you can use pH to control the growth of
bacteria. Generally, food is considered to be in a safe
pH range when the final pH is 4.6 or below.
Atmosphere
Some bacteria require a specific type of atmosphere for
growth. Microorganisms are categorized as aerobes,
anaerobes, facultative anaerobes and microaerophilic.
Aerobes require oxygen and include such bacteria
as Bacillus. Anaerobes grow only in the absence
of molecular oxygen. These organisms include
Clostridium. Facultative anaerobes can grow whether
the environment has oxygen or not. Microaerophilic
is a term applied to organisms, which grow only in
reduced oxygen environments. Knowledge of the
atmosphere surrounding the food is an especially
important consideration in determining which pathogens
are likely to be a problem.
Water Activity
Fresh meats, fish, fruits, and vegetables
0.98 or above
Cured meat, processed cheese, bread
0.93 – 0.98
Dried meat, aged cheddar cheese
0.85 – 0.93
Cereal, flour, jam, nuts, salted fish
0.60 – 0.85
Chocolate, honey, noodles
0.60 or below
Most bacteria will not grow when the water activity is 0.85 or less. Many yeasts and molds can grow
below this level but this is a spoilage concern and generally not a food safety concern.
3-2
Table 3-1 lists some of the most important characteristics
of growth for common foodborne pathogens. The
appendix at the end of this manual lists more detailed
information on specific food borne bacterial pathogens.
Use this information in evaluating your foods or
processes for potential bacterial hazards.
Chemical Hazards
A wide variety of chemicals are routinely used in the
production and processing of foods. Some examples of
common types of chemicals are listed in table 3-2. While
these types of chemicals may not be hazards if used
properly, some can cause illness if not used properly.
Therefore, the hazard analysis must consider whether
any of these chemicals is used in a manner which creates
a significant food safety problem.
Physical Hazards
Physical hazards are represented by foreign objects or
extraneous matter that are not normally found in food.
The presence of these items typically result in personal
injuries such as a broken tooth, cut mouth, or a case of
choking. Examples of Physical hazards are found in
Table 3-3. In some instances, physical contaminants
may also include “filth” such as mold mats, insects, and
rodent droppings. Although extraneous matter normally
categorized as filth may not actually injure a consumer,
some of these items can also contribute biological
hazards. For example, rodents and their droppings are
known to carry Salmonella species.
Table 3-1
BACTERIA - CHARACTERISTICS OF GROWTH
Temperature for
Growth (F°)
pH
Minimum Water
Activity (Aw)
39 – 131
4.3 – 9.3
0.92
Campylabacter jejuni
86 – 113.7
4.9 – 9.5
0.99
Clostridium botulinum
38 – 118
A: 4.6
E: 5.9
A: 0.94
E: 0.97
Clostridium perfringens
50 – 125
5.0 – 9.0
0.93
Escherichia coli
45 – 121
4.0 – 9.0
0.95
Listeria monocytogenes
31 – 113
4.4 – 9.4
0.92
Salmonella
41 – 115
3.7 – 9.5
0.94
Shigella
43 – 117
4.8 – 9.3
0.96
Staphylococcus aureus
45 – 122
4.0 – 10
0.83
Vibrios
41 – 111
4.8 – 11
0.94 – 0.97
Yersinis enterocolitica
30 – 108
4.2 – 10
0.95
Pathogens
Bacillus cereus
3-3
Table 3-2
EXAMPLES OF CHEMICAL HAZARDS
Location
Hazard
Pesticides, antibiotics, hormones, toxins,
fertilizers, fungicides, heavy metals, PCB’s
Raw Materials
Color additives, inks, indirect additives,
packaging materials
Direct food additives preservatives (high level of nitrates)
flavor enhancers
color additives
Processing
Indirect food additives boiler water additives
peeling aids
defoaming agents
Building and Equipment Maintenance
Lubricants, paints, coatings
Sanitation
Pesticides, cleaners, sanitizers
Storage and Shipping
All types of chemicals
Table 3-3
EXAMPLES OF PHYSICAL HAZARDS
Cause
3-4
Source
Glass
Bottles, jars, light fixtures, utensils, gauge covers, thermometers
Metal
Nuts, bolts, screws, steel wool, wire, meat hooks
Stones
Raw materials
Plastics
Packaging materials, raw materials
Bone
Raw materials, improper plant processing
Bullet/BB shot/Needles
Animals shot in field, hypodermic needles used for injections
Jewelry/Other
Rings, watches, pens, pencils, buttons, etc.
Preventative Measures are defined as: “Physical, chemical or other means that can be used to control an identified
food safety hazard.” The following tables provide examples of preventive measures for Biological, Chemical,
and Physical Hazards.
Table 3-4
EXAMPLES OF PREVENTATIVE MEASURES FOR BIOLOGICAL HAZARDS
Pathogen
Preventive Measure or Control
Bacillus cereus
Proper handling and cooling temperatures of foods; thermal processing
of shelf-stable canned food.
Campylobacter jejuni
Proper pasteurization or cooking; avoiding cross-contamination of
utensils, equipment; freezing; atmospheric packaging.
Clostridium botulinum
Thermal processing of shelf-stable canned food; addition of nitrite
and salt to cured processed meats; refrigeration of perishable vacuum
packaged meats; acidification below pH 4.6; reduction of moisture
below water activity of 0.93.
Clostridium perfringens
Proper handling and cooling temperatures of foods; proper cooking
times and temperatures; adequate cooking and avoidance of crosscontamination by unsanitary equipment.
E-coli 0157:H7
Proper heat treatment ; prevention of cross contamination; proper
refrigeration temperatures.
Listeria monocytogenes
Proper heat treatments; rigid environmental sanitation program;
separation of raw and ready-to-eat production areas and product.
Salmonella spp.
Proper heat treatments; separation of raw and cooked product; proper
employee hygiene; fermentation controls; decreased water activity;
withdrawing feed from animals before slaughter; avoiding exterior
of hide from contacting carcass during skinning; antimicrobial rinses
scalding procedures; disinfecting knives.
Shigella
Proper heat treatment; proper holding temperatures; proper employee
hygiene.
Staphylococcus aureus
Employee hygiene; proper fermentation and pH control; proper heat
treatment and post-process product handling practices; reduced water
activity.
Vibrios
Proper heat treatment; prevention of cross-contamination; proper
refrigeration temperatures.
Yersinia enterocolitica
Proper refrigeration; heat treatments; control of salt and acidity;
prevention of cross-contamination.
3-5
Table 3-5
EXAMPLES OF PREVENTIVE MEASURES FOR CHEMICAL HAZARDS
Hazard
Preventive Measure
Naturally-occuring
Substances
Supplier warranty or guarantee; verification program to test each
supplier’s compliance with the warranty or guarantee.
Added Hazardous
Chemicals
Detailed specifications for each raw material and ingredient; warranty
or letter or guarantee fro the supplier; visiting suppliers; requirement
that supplier operates with a HACCP plan.
In-Process Chemicals
Identify and list all direct and indirect food additives and color
additives; check that each chemical is approved; check that each
chemical is properly used; record the use of any restricted ingredients.
Table 3-6
EXAMPLES OF PREVENTIVE MEASURES FOR PHYSICAL HAZARDS
Hazard
Preventive Measure
Foreign objects in raw
materials
Supplier’s HACCP plan; use of specifications, letters of guarantee;
vendor inspections and certification; in-line magnets; screens, traps,
and filters; in-house inspections of raw materials.
Foreign objects in
packaging materials,
cleaning compounds, etc.
Supplier’s HACCP plan; use of specifications, letters of guarantee;
vendor inspections and certification, in-house inspections of raw
materials.
Foreign objects introduced
by processing operations
or employee practices
In-line metal detectors; visual product examinations; proper
maintenance of equipment; frequent equipment inspections.
You should now be able to identify many types of hazards. You should also know where to begin looking for their
preventative measures.
3-6
Principle 1: Hazard Analysis
Conduct a hazard analysis. Prepare a list of steps in the process where significant
hazards occur and describe the preventative measures.
A thorough hazard analysis is one of the keys to building an effective
HACCP plan. The hazard analysis process involves identifying hazards that
are reasonably likely to occur in the absence of control and their preventive
measures. In the first “Identification” stage, the HACCP team identifies and
lists food safety hazards that may be introduced or increased at each step in
the production process.
Then, in the second “Evaluation” stage, each food safety hazards is evaluated
based on how likely it is to occur. The term “reasonably likely to occur” is the
ruler against which each hazard can be measured. Also during this evaluation
stage the HACCP team investigates the appropriate preventative measures that
will control the “likely to occur” food safety hazards.
[Hazards can vary greatly from one store to another due to differences in sources
of ingredients, product formulations, processing equipment, processing methods,
duration of the processes, and storage methods. Make sure that your hazard
analysis takes into account what’s unique about your establishment.]
Preventive Measures:
When determining the appropriate
preventative measure for an
existing food safety hazard, keep
in mind the wealth of regulatory,
scientific, and historical support.
Over the years, both industry and
regulators have done a lot of work
in identifying food safety hazards
and preventative measures that can
be used to control them in food
production. Don’t think that you
have to go it alone in this search.
Hazard Identification and Evaluation
The following steps can help you and the HACCP team get started conducting your hazard analysis.
1
Here are some questions you can ask yourself to better understand the hazard identification
process:
• Are additives or preservatives added to the product to kill or inhibit the growth of bacteria?
• Will the amount of acidic ingredients affect the growth/survival of bacteria?
• Does the product need to be refrigerated/frozen or kept dry in storage and during transit?
2
Second, look at the product ingredients that you listed earlier. In order to find all of the food safety
hazards that are reasonably likely to occur, you need to know detailed characteristics about all the
ingredients used in your process, as well as possible ingredient interactions.
Here are some questions you can ask about the ingredients:
• Could these ingredients contain any pathogenic bacteria, dangerous chemicals, or harmful
physical objects?
• If contaminated or mishandled, could the ingredients or materials support the growth of
pathogenic bacteria?
• Are hazardous chemicals used in growing, harvesting, processing or packaging an ingredient?
• Is this ingredient hazardous if used in excessive amounts?
3-7
3
Third, determine if any food safety hazards exist for each processing step listed in the process flow
diagram.
Here are some questions you can ask for each production step:
• Could contaminants reach the product during this processing
step?
• Could this step create a situation where an ingredient, work
in process, or finished product becomes contaminated with
pathogens?
• Could this step introduce a chemical or physical hazard into the
product?
Possibilities for the three questions above include: worker
handling, contaminated equipment or materials, crosscontamination from raw materials, leaking valves or pipes,
splashing, etc.
• Could bacteria multiply during this process step to the point
where they became a hazard? Consider product temperature,
hold temperature, etc.
How can you be sure that
you are producing safe food?
A properly functioning HACCP
system assures the safety of your
product. Critical Control Points
exist in your establishment already.
HACCP helps you to identify and
use them to control food safety
hazards. The system of HACCP,
(specifically the correct identification
and monitoring of CCP’s) is what
makes the answer to that question a
sure thing.
KEEP GOOD NOTES: A summary of the HACCP team meetings and the reasons for each decision
during the hazard analysis should be kept for future reference. These documents will be a great help to
you when you have to review and update your hazard analysis and HACCP plan.
Finding Preventive Measures
Now that you have a good idea of what you’re looking for in the way of hazards. Use the example tables
of preventive measures on pages 3-5 through 3-6 to use as a reference to find out some ways to keep those
hazards under control.
It is sometimes the case that more than one preventive measure may be required to control a specific hazard,
or that more than one hazard may be controlled by one preventive measure. As you go through the hazard
analysis, you may recognize preventive measures already in place in your production processes.
The key to a successful hazard analysis is to link the preventive measures to the food safety hazards you have
just identified.
Here’s A Tip
When sitting down to figure out which steps in
your process might or might not be CCP’s, a
common pitfall is to name too many.
3-8
Working with the “Hazard Analysis” Form
To explain how this form works, we are going to show you three production steps for which the Example
Facility did a hazard analysis. The form is structured so that the three food safety hazard categories (chemical,
biological, physical) are addressed in each of the four questions. Don’t forget that you need to fill out the top
of the form with the appropriate information, such as the product/process name, and the process steps from the
flow diagram. You also need to sign or initial and date the form when it’s complete.
The first production step we’re going to look at is receiving meat.
1
2
3
For the first question all you need to do is state what food safety hazards are present at that step.
The Example Facility listed pesticides, hormones, and antibiotics as a chemical hazard. They listed
pathogenic bacteria as a biological hazard because bacteria is found on all raw meat. They also listed
plastic and bone fragments as physical hazards because the meat comes to them in plastic sheaths.
The second question asks you to decide whether or not the hazard is reasonably likely to occur at that
step. The Example Facility answered “No” for the chemical, “Yes” for the biological, and “No” for the
Physical.
The third question is where you explain why you answered “Yes” or “No”, to the question of
“reasonably likely to occur.” For the chemical hazard, the Example Facility’s justification is that these
sources are normally within defined limits. For the biological hazard they assume that the bacteria is
on the meat prior to arrival, so that it continues to be a potential hazard. They said “No” to both the
plastic and bone fragments because in both cases there has never historically been a problem with these
types of physical hazards in their facility.
[This “historical” basis for deciding whether a food safety hazard is “reasonably likely
to occur” is perfectly legitimate. If your facility has a clean track record regarding
a particular hazard, it’s fine to include that information in your HACCP plan. All
information must be documented.]
4
The final question on the hazard analysis form is the place where you write the specific preventive
measure(s) that will control the hazard you said was likely to occur. With each shipment of meat
the Example Facility receives they feel that the “Letter of Guarantee” from their supplier reasonably
assures them the meat has been kept at a temperature adequate to control bacterial growth. However,
just because they have one preventive measure hasn’t stopped
them from also having a second preventive measure. They also
visually check the condition and temperature of the truck and
meat products, to make sure everything meets their
standards.
3-9
3-10
The second production step we’re going to look at is cooking.
1
List the hazards. The Example Facility listed a chemical hazard of sanitizing chemicals because it’s
possible that traces of these substances could be on the equipment from the last time it was cleaned.
They also listed a biological hazard because bacteria is unavoidable on all raw meat.
[If you don’t find a particular type of hazard at a step it’s okay to write “Non Identified”
as the Example Facility did.]
2
3
Is it “reasonably likely to occur”? They answered “No” for the chemical hazard, and “Yes” for the
biological hazard.
What is the basis for your decision? The Example Facility decided the sanitizing chemicals
wouldn’t be a hazard likely to occur because their proper use is thoroughly covered by existing
Sanitation Standard Operating Procedures (SSOP’S). They decided “Yes” for the biological hazard for
the same reason as in the preceding process step.
[When working on your HACCP plan, you might want to revisit your SSOP’s]
4
What are the preventive measures? The Example Facility identified two preventive measures,
cooking and water activity reduction for the biological hazard. They said this is because the cooking
and the water activity reduction will help to reduce the hazard.
3-11
3-12
The third production step we’re going to look at is cooling.
1
2
3
4
List the hazards. The Example Facility listed the biological hazard of cross-contamination because
any time when you have raw and finished product in the same facility the possibility for the raw product
to cross-contaminate the finished product exists. The Example Facility also listed plastic as a physical
hazard because this is the step where they “Pull” the jerky strips off the cooking trees into large plastic
barrels.
Is it “reasonably likely to occur”? The Example Facility answered, “No” for the biological, and “No”
for the physical.
What is the basis for your decision? The Example Facility said that the biological hazard was not
likely to occur because the raw and cooked products are strictly kept apart as called for in their SSOP’s.
They said “No” to the physical hazard because the plastic barrels that are used are made of an extremely
sturdy type of plastic and there’s never historically been a problem with plastic shavings at this facility
getting into the jerky.
What are the preventive measures? There aren’t any preventive measures listed here because no food
safety hazards were found to be reasonably likely to occur.
These forms are just one way of documenting the
hazard analysis process. An alternative form can
be found on page 5-14.
3-13
3-14
Principle 2:
Identify Critical Control Points
A critical control point is defined as “A point, step or procedure in a food process at which control can be
applied and is essential to prevent or eliminate a food hazard or reduce it to an acceptable level.” Everything
in your HACCP plan revolves around the proper identification of CCPs.
Some of the most common CCPs are:
• Chilling or freezing to a specified temperature to prevent bacteria from growing.
• Cooking that must occur for a specific time and temperature in order to destroy bacteria.
• Prevention of cross-contamination between raw and cooked product.
• Certain processing procedures, such as filling and sealing cans, mixing and spicing, etc.
• “pH”.
• Holding at proper refrigeration temperatures.
These are just a few examples of possible CCPs. Different facilities, preparing the same food, can identify
different food safety hazards and different critical control points. Usually no two stores have the same floor
plan, equipment, or ingredients. The CCPs you identify will reflect the uniqueness of your processing facility.
One of the tools used to help determine critical control points is a “CCP Decision Tree.” The use of a Decision
Tree to identify significant hazards is not necessary for you to meet regulatory requirements. However,
the thought process may be helpful for your team; you want to make sure that your HACCP system meets
regulatory requirements.
Working with the “CCP Decision Tree” Form
Numbering your CCP’s:
Once you’ve been through your entire production process and have successfully identified all the CCP’s
there’s one more thing you need to do to get that CCP set up. You need to organize them. Feel free to
do this anyway that works for your business.
One easy way to accomplish this is to develop a simple numbering system. It’s a good idea to always write
“CCP” before the numbers - this can make your documents easier to understand. For instance you could
write it like: CCP#1, CCP#2, CCP#3.
Also remember that you could have more than one CCP (for a designated food safety hazard) at a given
process step or one CCP may control more than one hazard. In this case you might want to include the
letter “B”, “C” or “P” to identify whether it is a biological, chemical or physical hazard. For example:
CCP#1B, CCP#1C, CCP#2P, CCP#2C.
3-15
The Example Facility used the CCP Decision Tree to take a closer look at both of the steps in their process
where they determined food safety hazards were reasonably likely to occur. [Go ahead and read the four
questions on the form and then we’ll look at each one in detail. Again, this approach is not necessary to meet
regulatory requirements.
The first step they looked at was receiving meat.
Question 1a
The Example Facility answered “Yes” because the “Letter of Guarantee” from the supplier, and checking
the temperature of the truck and products are the preventive measures for this biological hazard.
Question 1b
If you answered “Yes” for question 1a, then you don’t need to worry about question 1b. (If you haven’t
yet identified a preventive measure for a food safety hazard, question 1b will not let you move down the
CCP Decision Tree until you do.)
Question 2
This question asks whether or not this step “prevents, eliminate, or reduces” to acceptable levels, the
food safety hazard you are working with. The Example Facility said “No” because simply receiving the
meat doesn’t mean the hazard is controlled.
Question 3
The Example Facility said “Yes” here because, if not controlled, the biological hazard could get worse.
Question 4
Here the HACCP team must decide if this step is the last point at which control could be applied to the
hazard. In this case the Example Facility found that, in fact, a later step (i.e. cooking) could control this
biological food safety hazard. This process step was not a CCP.
3-16
Critical Control Point
Decision Tree
Receiving Meat
For the production of cooked products. Process Step ______________
Question 1A
Do preventative measures exist for the identified hazards?
If no - go to Question 1B.
If yes - go to Question 2.
Yes, go to Question #2
Question 1B
Is control at this step necessary for safety?
If no - not a CCP
If yes - modify step, process or product
and return to Question 1.
Question 2
Does this step eliminate or reduce the likely
occurence of a hazard(s) to an acceptable level?
If no - go to Question 3.
If yes - CCP.
No
Question 3
Could contamination with identified hazard(s) occur
in excess of acceptable levels or could these increase
to unacceptable levels?
If no - not a CCP.
If yes - go to Question 4.
Yes
Question 4
Will a subsequent step eliminate the identified
hazards or reduce the likely occurence to an
acceptable level?
If no - CCP.
If yes - not a CCP.
Results:
NOT a CCP.
NOT a CCP.
Yes - so it’s NOT a CCP.
BIOLOGICAL
T CCP#______________
T Not a CCP
CHEMICAL
T CCP#______________
T Not a CCP
PHYSICAL
T CCP#______________
T Not a CCP
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
Verified by: ___________________________
Date ____________
Mary Weston
12/12/98
3-17
The second step they looked at was cooking.
Question 1a
The Example Facility answered “Yes” here because they had identified the preventive measure of
cooking (i.e. time and temperature) for this step.
Question 1b
As in the receiving example, move on to question 2.
Question 2
The Example Facility said that “Yes” cooking would eliminate the hazard at this step. They stopped here
at question 2 because they reached a positive result...their CCP. Thus, there wasn’t any need to go on to
questions 3 and 4.
[After finding all the CCP’s in your process, the HACCP team needs to organize them. At the bottom of
the CCP Decision Tree Form the Example Facility named the cooking CCP “CCP#01B”. The “01” tells
them what number the CCP is, and the “B” tells them it is a biological food safety hazard.]
3-18
Critical Control Point
Decision Tree
For the production of cooked products. Process Step _______________
Cooking
_
Question 1A
Do preventative measures exist for the identified hazards?
If no - go to Question 1B.
If yes - go to Question 2.
Question 1B
Is control at this step necessary for safety?
If no - not a CCP
If yes - modify step, process or product
and return to Question 1.
Question 2
Does this step eliminate or reduce the likely
occurence of a hazard(s) to an acceptable level?
If no - go to Question 3.
If yes - CCP.
Question 3
Could contamination with identified hazard(s) occur
in excess of acceptable levels or could these increase
to unacceptable levels?
If no - not a CCP.
If yes - go to Question 4.
Question 4
Will a subsequent step eliminate the identified
hazards or reduce the likely occurence to an
acceptable level?
If no - CCP.
If yes - not a CCP.
Yes, go to Question #2
Yes,
Identified as a CCP
Results:
BIOLOGICAL
T CCP#______________
#01B
T Not a CCP
NOT a CCP.
-done
NOT a CCP.
NOT a CCP.
CHEMICAL
T CCP#______________
T Not a CCP
PHYSICAL
T CCP#______________
T Not a CCP
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
Mary Weston
12/12/98
Verified by: ___________________________
Date ____________
3-19
Principle 3: Establish Critical Limits for Each
Critical Control Point
A critical limit is defined as “The maximum or minimum value to
which a physical, biological, or chemical hazard must be controlled
at a critical control point to prevent, eliminate, or reduce to an
acceptable level the occurrence of the identified food safety
hazard.” You can think of a critical limit as a boundary of safety
for a CCP. The critical limit is the numerical value that must be
reached to assure that hazards have been controlled. An example
would be that “all sausage products must be cooked to 155o F for 15
seconds.”
Each CCP will have at least one (possibly more) preventive measures that need
to be controlled to assure this prevention, elimination or reduction of food safety
hazards. To be effective, each critical limit should be:
1.
Based on proven factual information.
A few ways that information and recommendations for appropriate limits can be obtained are: from
regulatory requirements, scientific literature, and consultation with experts. If regulatory requirements
exist they must be met or exceeded.
2.
Objectives are measurable or observable, such as time and temperature.
3.
Appropriate and reasonable for the food product and operation.
You should consider the type of equipment, the volume of product being produced, how the critical
limit will be monitored and frequency of monitoring.
4.
Specifics
When drafting your critical limits be specific in your language.. Use action words, and be specific when
naming people and equipment. An example could be “bake, uncovered in preheated 350oF oven to an
internal temperature of 165oF for 15 seconds.”
The HACCP team will find that many critical limits for your identified CCP’s have already been established.
In some cases you’ll need more than one critical limit to control a particular hazard. For example, the
typical critical limits for cooked beef pattied are time/temperature, patty thickness, and conveyor speed. It is
important that you identify all the critical limits for each of your products.
Making sure each Critical Control Point has critical limits is the responsibility of each establishment. The
HACCP team may want to get help from outside HACCP experts when establishing critical limits. Remember
that the critical limits must be able to maintain control over the food safety hazard. Once the team has
identified all the limits, enter them onto the Critical Limits form.
3-20
Here are some controls commonly used as preventative measures.
• Time and Temp - The temperature “danger zone” for biological hazards is between
40oF and 140oF. Bacteria grows fast! They have the ability to multiply rapidly. Knowing
this shows that controlling how long the product is in the danger zone (if at all) presents
itself as an extremely effective critical limit.
•pH - The pH of a food product is the level of its acidity or alkalinity. The pH is
measured on a scale of 0 to 14. The middle of the scale, pH=7.0, is considered
neutral. Altering a food product’s pH, such as adding an acidic substance like vinegar
or soy sauce will decrease the growth rate of the bacteria.
• Water Activity - In addition to warm temperatures and a median pH, bacteria also need
water to grow. Water activity (AW) refers to the amount of water in a food product that
is available, or free, for bacteria to use for growth and multiplication. Solutes (salts and
vinegars), as well as dehydration, decrease the available water and can reduce bacterial
growth.
Working with the “Critical Limits” Form
For each CCP the Example Facility has a separate page of critical limits.
1.
Under the “Limit” heading.
The Example Facility noted an internal temperature of 165oF for 15 seconds as the established critical
limit. They then decided that the preventive measure of cooking at 190oF oven temperature for 3
hours would satisfy the critical limit.
2.
Under the “Source” Heading.
The Example Facility’s first source is regulatory and scientific. They decided to take the established
regulatory limits and use them, but then they also sent out samples of their finished product to be
scientifically analyzed. The results of the lab tests confirmed that their critical limits were enough.
[The source is the “evidence” that backs up your critical limits. The source provides that the critical
limits you cite will effectively control the food safety hazards. Sources for critical limits can be
scientific, regulatory or historical. The HACCP team has to find at least one source for each of your
critical limits, but you can always put more if you want.]
Documenting
the
Source
When determining your critical limits make sure you file your supporting
documentation with your HACCP plan. This documentation will help
validate that the limits have been properly established. These could be
things such as letters from outside HACCP experts, or scientific reports,
or lab test results. By holding onto these supporting documents you also
provide verification material when needed.
3-21
3-22
Principle 4: Establish Monitoring Procedures
Monitoring involves a series of observations and/or measurements that are used to make sure a CCP is under
control. The HACCP team can think of monitoring activities as the checks-and-balances for each CCP. When
someone monitors, they are “checking to see” that the critical limits are being met.
What are the 3 things monitoring can do for you?
• shows you when a deviation from a critical limit has happened. For example, an employee tests
the temperature of some beef patties and discovers that the internal temperature has gone above the
established critical limit of 40oF. If not caught here, this would be a potentially serious health risk to
consumers.
• helps you identify trends in your process that will allow you to predict a loss of control at a CCP. For
example, a facility may monitor the temperature of a cold storage area at 6 am., 8a.m., and 10 a.m.
Each time, the temperature is within acceptable limits, but it is steadily climbing toward the high end
of the range. This information points towards a trend, and the facility should take action to prevent the
temperature from exceeding the critical limits.
• produces written records for use in future HACCP plan verification steps.
Written monitoring records will prove very valuable to your operation, should a serious problem along
the production line occur. The records you keep prove that your company has established and carried out
effective monitoring techniques.
Monitoring procedures can be thought of as continuous or non-continuous.
• Continuous monitoring is the constant monitoring of a critical control point.
• Non-continuous monitoring is the scheduled monitoring of a critical control point.
Continuous monitoring is always preferred when feasible. Continuous monitoring at a CCP is usually done
with built-in measuring equipment, such as a recording thermometer used at a cooking step. This type of
monitoring is preferred because it yields a permanent record. To make sure these activities stay accurate, you
need to regularly check the monitoring equipment to make sure that it is calibrated correctly.
If continuous monitoring isn’t feasible for your CCP then the HACCP team will need to establish noncontinuous monitoring procedures. Non-continuous doesn’t mean random. The team should decide in the
development phase what the monitoring schedule should be. When you use non-continuous monitoring,
make sure that it’s scheduled often enough to keep the food safety hazards under control. Expert advice from
people with knowledge of practical statistics and statistical process control will be important in making your
decisions. Types of non-continuous monitoring procedures include visual examinations, monitoring ingredient
specifications, measurements of pH or water activity (Aw), taking product temperatures, etc.
Who’s Responsible?
Make sure to assign a specific person to be responsible for the monitoring
of a CCP. The Example Facility has a designated shift leader/cook who is
responsible for monitoring the cooking CCP. The person who actually
does the monitoring must be the person who signs and dates all the
records at the time of monitoring.
3-23
Monitoring will be most effective when:
• The HACCP plan clearly identifies the employee(s) responsible for monitoring.
• Employees are trained in the proper testing procedures, the established critical limits, the methods of
recording monitoring results, and the actions to be taken when critical limits are exceeded.
• Employee(s) understand the purpose and importance of monitoring.
The last step in establishing your monitoring procedures is to develop the Monitoring Log(s) where the
monitoring person will record the date for each CCP. Due to the variety of monitoring procedures, the HACCP
team may need to developed different logs to record the monitoring data at different CCP’s. When your
HACCP system is up and running, you will use these logs to track the day-to-day HACCP activities. Sample
logs are provided in the Appendix.
Working with the “Monitoring Procedures” Form
The form that is shown as an example on the next page is to be used as a tool in the development of your
HACCP plan. The information on this form is the “Who, What, When and How” of monitoring.
For the Example Facility:
• The Who is the cook on duty.
• The What is the temperature of the oven.
• The When is non-continuously - every 60 minutes, (+ 5 minutes), and
• The How is with the oven temperature gauge.
The Example Store felt this type of non-continuous monitoring would be effective because of the consistent
heat environment of the oven. Their logic was that if the temperature taken at the beginning and end of the
cooking cycle was the same, it could reasonably be assumed that it was okay for the whole cooking cycle.
Remembering your Monitoring
The key to effective and reliable monitoring is to keep it simple and build it into the employees’
normal routines. When establishing a time for the actual monitoring procedure, allow some
flexibility. For example, if you say you will monitor a CCP at 10 a.m. and the person is not
there at exactly 10 a.m., you could be opening yourself up for problems. It is suggested that
you specify a period of time during which monitoring will occur. For example, write your time as
“10a.m. +/-- 10 minutes”or “between the time period of 10 a.m. and 10:15 a.m.”
3-24
HACCP Principle 4
Monitoring Procedures Form
Beef Jerky/Heat Treated, Shelf Stable
Product/Process Name: _______________________________________
Cooking
CCP #01B
Process Step/CCP: ____________________________________________
Monitoring Procedures - (Who, What, When, How) ________________________________
The cook on duty records the oven temperature at intervals of 60 minutes, ( 5 minutes)
starting
when a “lot” is placed in the oven and ending when the “lot” is removed from oven.
_____________________________________________________________________________
Each
oven is monitored individually using an oven temperature gauge.
_____________________________________________________________________________
+
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
3-25
Principle 5: Establish Corrective Actions
Corrective Action can be defined as “Procedures to be followed when a deviation occurs.” A deviation is
defined as a “failure to meet a critical limit.”
Deviations can and do occur. After the HACCP team has established strict monitoring procedures, the next
step is to draft corrective actions to be taken immediately when there is a loss of control at a CCP.
Corrective action may include, but is not limited to the following procedures:
1.
2.
3.
4.
5.
6.
Identifying and eliminating the cause of the deviation,
Demonstrating that the CCP is once again under control. (This means examining the process or product
again at that CCP and getting results that are within the critical limits.),
Taking steps to prevent a recurrence of the deviation,
Making sure that no adulterated product enters commerce, and
When to discard product.
Maintaining detailed records of the corrective actions.
If a deviation occurs that is not covered by a specific corrective action in your HACCP plan, or if some
unforeseen hazard arises, appropriate steps should be taken. These steps shall include, but not be
limited to:
1.
2.
3.
4.
5.
Segregate and hold any affected product until its acceptability can be determined.
Determine the acceptability of the affected product for distribution.
Do not allow product that is injurious to health or is otherwise adulterated to enter commerce.
Reassess and, if necessary, modify your HACCP plan to properly address this type of deviation in the
future.
Maintain detailed records of your actions.
Some examples of corrective actions are:
• Changing the process and holding the product for further evaluation.
• Empowering the monitoring personnel to stop the line when a deviation occurs. They should have the
authority to hold all “lots” of a product not in compliance.
• Rely on an approved alternate process that can be substituted for one that is out of control at the
specific CCP.
• Additional cooking time.
• Quickly cooling product.
Whatever type of corrective actions the HACCP team establishes, records for each one need to be kept
that include:
• That the deviation was identified.
• The reason for holding the product, the time and date of the hold, the amount of the product involved,
and the disposition and/or release of the product.
• The actions that were taken to prevent the deviation from recurring.
• The dated signature of the employee who was responsible for taking the corrective action.
As with monitoring logs, the HACCP team also needs to develop the log(s) for the corrective action results.
3-26
Working with the “Corrective Action Procedures” Form
The Example Facility’s corrective action form outlines exactly what they think should be done if a problem
occurs with the CCP#01B.
• Under the “Problem” heading.
They state the critical limit that has been established for this CCP.
• Under the “Disposition of Product” heading.
If a deviation occurs, they have noted that the initial disposition would be to hold the product “lot”, and
try to rework it if possible. The “rework” would consist of fixing the temperature and re-cooking the
jerky.
• Under “Corrective Action Procedures/Steps” heading.
As you can see, the Example Facility listed quite specific corrective actions for this CCP. Their
directions are written concisely, and in the order they should be performed.
• Under the “Who is Responsible” heading.
They are specific in naming a particular person.
• Under the “Compliance Procedures” heading.
The Example Facility has projected that if this deviation happens at this CCP it will probably be
because something went wrong with the thermostat in the oven. They list here what will probably
need to be done to make sure this doesn’t happen again. (If this deviation were to actually happen, the
monitoring person would write on the corrective action log what he or she did to fix the problem, and
what they did to make sure it wouldn’t happen again.)
Stopping Production
The more ownership the employees feel they have in the HACCP system, the more effective
they will be in ensuring that your facility produces safe food.
One idea is to empower the person responsible for monitoring to be able to stop production
when and if a deviation occurs. This accomplishes two important functions.
• First, it prevents the potentially hazardous product from continuing down the production
line.
• Second, it makes timely communication easier; thus you find out what’s happening in
your facility as soon as possible.
3-27
HACCP Principle 5
Corrective Action Procedures Form
Beef Jerky/Heat Treated, Shelf Stable
Product/Process Name: _______________________________________
Cooking
CCP # 01B
Process Step/CCP: ____________________________________________
Problem - (Critical limit exceeded) _______________________________________________
Oven temp, below 190 degrees Fahrenheit
____________________________________________________________________________
Disposition of product - (Hold, Rework, Condemn)_________________________________
Hold, rework if possible.
_____________________________________________________________________________
1.Identify and segregate affected product, place on hold.
2.
Rework if possible, otherwise condemn product: Reestablish correct cooking procedures (i.e.
_____________________________________________________________________________
fix
oven temp. settings, or move product to other oven for rework.)
_____________________________________________________________________________
3.
Determine cause of deviation: broken oven thermostat.
_____________________________________________________________________________
4.
Take steps to prevent recurrence: recalibrate/replace thermostat
_____________________________________________________________________________
5.
Notify Quality Control Supervisor a.s.a.p.
__________________________________________________________________________
Who is responsible for performing these corrective actions?__________________________
John Smith - Cook
on__________________________________________________________________________
duty
Corrective action procedures/steps _______________________________________________
Compliance procedures________________________________________________________
Recalibrate/Replace
oven thermostat.
_____________________________________________________________________________
Monitor
CCP as usual during rework.
_____________________________________________________________________________
Cindy Jones
12/14/98
Developed by: _________________________
Date ____________
3-28
Principle 6: Establish Record Keeping Procedures
The records you keep for HACCP can make all the difference! Good HACCP records - meaning that they are
accurate and complete - can be a great help to you. Here’s why:
• Records make it possible to trace ingredients, in-process operations, or finished products, should a
problem occur.
• Records help you identify trends in your production line.
• Records serve as written documentation of your facility’s compliance with the HACCP regulations.
Well maintained records protect both your customers and YOU.
Your HACCP records should include your development forms and your daily logs for each CCP. You should
also keep your hazard analysis development forms, your CCP determination sheets, a list of critical limits for
each food safety hazard, clear corrective action instructions, and a copy of your compiled HACCP plan. When
first establishing your recordkeeping procedures, it’s better to think of the different kinds of records you’ll need
in two ways.
First, there are records that are used for development for archival purposes; such as your Hazard Analysis,
and your CCP decision making tool.
Second, there are records that you will work with on a day-to-day basis. These are the logs we’ve been
discussing such as the monitoring or corrective action logs. As we’ve said before, the HACCP team
will need to create these logs for each CCP in your process.
The Minnesota Food Code requires that you keep records on specified information; see page 4-3 for further
detail. Regardless of the type of record, all HACCP records must contain at least the following information:
•
•
•
•
•
Title and date of record.
Product identification,
Signature of employee making entry,
A place for the reviewer’s signature, and
An orderly manner for entering the required data.
Working with the “Recordkeeping
Procedures” Form
• Under the “Records” heading.
You can see that the Example Facility has filled out
their Recordkeeping Form making sure to list both the
development forms (the hazard analysis), and the logs.
[One last note about the records you keep. When developing and
working with your forms and logs remember to use ink (ballpoint
pen) - no pencils. On all records, whenever you make a change,
mark through the original and initial. Do not erase, white out,
or mark the original so that it is unreadable.]
Tips on Designing Records
One way to approach development
of the recordkeeping requirements
of your HACCP system is to
review the records you already
keep, and see if they are suitable,
in their present form or with minor
modifications, to serve the purposes
of your HACCP system. The best
recordkeeping system is usually
the simplest one that can easily
be integrated into the existing
operation.
Place a blank copy of all logs/forms in the HAACP plan to show how you record this information.
3-29
HACCP Principle 6
Recordkeeping Procedures Form
Beef Jerky/Heat Treated, Shelf Stable
Product/Process Name: _______________________________________
Cooking
CCP # 01B
Process Step/CCP: ____________________________________________
Records
Name: Hazard Analysis
Location: Office File
Cabinet
Name: HACCP Plan Re- Name: Monitoring Log view Sheet - For each CCP For each CCP
Location: Oven Room Wall Location: Oven Room Wall
Name: Process - Monitoring
Name: Deviation /
Equipment Calibration Log Name: Verification ProceCorrective Action Log
- For each CCP
dures & Results Log - For
each CCP
Location: Oven Room Wall Location: Oven Room Wall
Location: Oven Room Wall
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
3-30
Principle 7: Establish Verification Procedures
Your team needs to decide on what procedures the facility will perform to verify that the HACCP system is
working effectively and how often these actions will be performed. Verification uses methods, procedures,
or tests in addition to those used in monitoring to see whether the HACCP system is in compliance with the
HACCP plan or whether the HACCP plan needs modification. There are three types of verification. These are
initial validation, ongoing verification, and reassessment of the HACCP plan.
Initial Validation
Validation is defined as” the specific and technical process for determining that the CCP’s and associated
critical limits are adequate and sufficient to control likely hazards.” The initial validation of your HACCP plan
is the process by which your establishment proves that what is written in the HACCP plan will be effective in
preventing, eliminating, or reducing food safety hazards. This validation activity is the exclusive responsibility
of your establishment.
You carry out this validation by gathering evidence that supports your HACCP plan. The data you bring
together can come from many sources. Such sources may include scientific literature, product testing results,
regulatory requirements, and /or industry standards. Companies have a lot of flexibility in the compilation of
this information in regards to the sources and the amounts of such data.
[Most likely, you already have the majority of the validation information you need. When you conducted your
hazard analysis and researched the sources for your critical limits, you were collecting data that could also be
used to validate your entire HACCP plan.
Ongoing Verification
Verification is “the use of methods, procedures , or tests in addition to those used in monitoring, to determine
whether the HACCP system is operating as intended.” After a HACCP plan has been initially validated and
put into action, verification activities continue on an ongoing basis.
Simply stated, you need to verify that your HACCP system is working the way you expected. There are
several ways to do this, here are a few: (these aren’t the only ones)
• Calibrate your monitoring equipment.
• Sample your product.
• Review your monitoring and corrective action logs.
• Personally inspect your facility’s operations.
Whatever types of ongoing verification activities you decide to
use, they should be included in your HACCP plan along with
the specifics on your CCP’s, critical limits, monitoring, and
corrective actions. Also, the HACCP team needs to identify the
schedules for conducting the verification checks.
3-31
Reassessment of the HACCP Plan
It is a good idea to reassess the adequacy of your plan at least once a year and whenever any new changes
occur that could affect the hazard analysis or alter the HACCP plan. Here are a few, but not all, of the changes
that would require modification to your HACCP plan.
1.
2.
3.
4.
5.
6.
Potential new hazards are identified that may be introduced into the process.
New ingredients are added, or when an ingredient supplier is changed.
The process steps or procedures are changed.
New or different processing equipment is introduced.
Production volume changes.
Personnel changes.
Your reassessment should include a review of the existing HACCP plan, including the product evaluation, hazard
analysis, critical control points, critical limits, monitoring procedures, corrective actions and recordkeeping
procedures.
Working with the “Verification Procedures” Form
It’s important to remember that verification procedures are ongoing activities. For each CCP you will need a
monitoring log, a deviation/corrective action log, and an equipment calibration log. These logs are the continual
verification that HACCP is being done effectively.
(Like the monitoring form in principle 4, the information on this form is the “Who, What, When and How” of
verification.)
For the Example Facility:
• The Who is the quality control supervisor.
• The What is each one of the three activities they need for their process,
• The When is specified after each activity, and
• The How would be determined as needed by the quality control supervisor.
Finishing Your HACCP Plan
Each form that is used in the development of the HACCP plan and the HACCP plan itself needs to be reviewed
in its entirety and signed and dated by the responsible official on the HACCP team. This person must make sure
that the HACCP plan is complete. This assures the HACCP team that only the most complete and up-to-date plan
is being used.
The HACCP System
The HACCP Plan is a written document that is based on the 7 principles of HACCP. A HACCP System is the results
of the implementation of the HACCP plan. It includes the written HACCP plan itself but also any records produced,
verification data and any prerequisite programs (either written plans or records for GMPs and SSOPs)
The HACCP system produces real results. HACCP is a way of getting and keeping control over your entire
production process.
3-32
HACCP Principle 7
Verification Procedures Form
Beef Jerky/Heat Treated, Shelf Stable
Product/Process Name: _______________________________________
Cooking
CCP # 01B
Process Step/CCP: ____________________________________________
Verification Procedures - (Who, What, When, How) ______________________________
Thermometer calibration - Weekly
Random observation of monitoring - Daily
____________________________________________________________________________
Review relevant records - Daily, prior to shipment
___________________________________________________________________________
Deviation response review - Ongoing
___________________________________________________________________________
Quality Control Supervisor
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
____________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Cindy Jones
12/10/98
Developed by: _________________________
Date ____________
3-33
4
Section
Minnesota Food Code
Requirement
Introduction
HACCP is a universal preventative system for assuring the safe production of food products.
The Preliminary Steps and Seven Principles of HACCP can be applied to most any food
production process including agriculture production, food processing, retail food preparation,
and distribution systems. Previous sections in this manual have focused on the basics of
developing a HACCP plan.
The Minnesota Food Code regulation applies to retail food establishments such as grocery
stores, restaurants, meat markets, convenience stores, bakeries, etc. Processes that require
operation under a HACCP plan were previously discussed in Section 1. Also included there
was timing of HACCP plans. It is important to note that new or extensively remodeled
establishments must submit the HACCP plan to the regulatory authority before the start of
operation for approval in conjunction with the facility plan review.
In this book, Section 2 focused on Preliminary Steps. Basically, the preliminary steps is a
method to collect information that is used in developing the HACCP plan. The Minnesota
Food Code requires that some of the preliminary steps information become part of your official
HACCP plan. Section 3 of this book focuses on developing the HACCP plan itself using the
Seven Principles. The Minnesota rule requires that most (although not all) of this information
become part of your official HACCP plan. In addition, the Minnesota Food code requires that
the HACCP plan for your retail food establishment contain some additional components. A
complete reference to the applicable Minnesota rules is provided in the Appendix.
4-1
Contents of a HACCP Plan
Minnesota Rules 4626.1735 - (8-201.14) state that for a food establishment that is required to have
a HACCP plan, the plan and specifications shall include:
1.
A categorization of the types of potentially hazardous foods that are specified in the menu.
*This information was collected in Preliminary Steps – Number 2. See page 1-5 for more information. Be
sure that this is included as one of the documents in your official HACCP plan.
2.. A flow diagram by specific food or category types identifying critical control points and providing
information on the following:
a. Ingredients, materials and equipment used in the preparation of a food.
b. Formulations or recipes that delineate methods and procedural control measures that address the
food safety concerns involved.
*This information was collected in Preliminary Steps – Number 3 and 4. See page 1-5 for more
information. Be sure that this is included as one of the documents in your official HACCP plan.
3.
A statement of Standard Operating Procedures for the plan identifying:
a. Critical control points.
b. Critical limits for each critical control point.
c. The method and frequency for monitoring and controlling each critical control point by the food
employee designated by the person in charge.
d. The method and frequency for the Person in Charge to routinely verify that the food employee is
following standard operating procedures and monitoring critical control points. (verification)
e. Action to be taken by the Person in Charge if the critical control points are not met. (corrective
action)
f. Records to be maintained by the Person in Charge to demonstrate that the HACCP plan is
properly operated and managed.
*Items 3a – f should all be included as part of your HACCP plan as developed in Section
3. The Person in Charge is ultimately responsible for ensuring that critical control points
are monitored and corrective action is taken as necessary and that records are maintained to
document this. The day-to-day activities could be assigned to an employee working in the HACCP
operation.
4.
Additional scientific data or other information as required by the regulatory authority supporting the
determination that food safety is not compromised by the proposal.
*Types of information that might need to be included here are validation data, or data to support a variance.
4-2
Compliance with the HACCP Plan
Minnesota Rules 4626.1730, Subp.3 state that in order to be in Compliance with the HACCP Plan a
licensee shall:
A. Comply with a properly prepared HACCP plan, and
B. Maintain and provide to the regulatory authority, on request, the records specified in part 4626.1735 ,
item A, sub-items (3) and (4) that demonstrate that the following are routinely employed:
1. Procedures for monitoring critical control points.
2. Monitoring of critical control points.
3. Verification of the effectiveness of an operation or process.
4. Necessary corrective actions if there is a failure at a critical control point.
When the rule requires that you prepare a HACCP plan for a certain operation, this HACCP plan
does, in effect, become part of the rule for your establishment. You must comply with your properly
prepared HACCP plan. By complying with the Standard Operating Procedures you have prepared as
part of your HACCP plan and when you have followed the steps in this publication for developing
a HACCP plan, you will have the necessary information to develop records that demonstrate that
critical point monitoring procedures are detailed and followed, that the process is verified for
effectiveness and that necessary corrective actions are taken as necessary.
Variances and the HACCP Plan
In several cases, when an establishment applies for a variance, the firm may be required to prepare and comply
with a HACCP plan for that operation. Operations that have this requirement are as follows:
1. Using more than one tagged shellstock container at a time
2. Deviating from required cook times and temperature for raw animal foods
3. Using molluscan shellfish life support system display tanks to store and display shellfish that
are offered for sale.
It is important to remember that the firm must first apply for and be granted a variance in prior to
conducting these operations.
4-3
1. Tagged Shellstock
Minnesota Rules 4626.0220, B (2) (b) states that that using more than one tagged or labeled container of
shellstock at a time requires obtaining a variance from the regulatory authority based on a HACCP plan that
includes procedures.
The HACCP facility must include procedures that:
1.
includes procedures that preserve source identification by using a record keeping system that keeps the
tags or labels in choronological order correlated to the date when, or dates during which, the shellstock
are sold or served, AND
2.
ensure the shellstock from one tagged or labeled container are not co-mingled with shell stock from
another container before being ordered by the consumer.
2. Deviating from Required Cook Times/Temperautres
MN Rules 4626.00340C states that the required cooking times and temperatures for raw animal foods do
not apply if the regulatory authority grants a variance based on a HACCP plan that:
1.
documents scientific data or other information showing that a lesser time and temperature regimen
results in a safe food, AND
2.
verifies that equipment and procedures for food preparation and training of food employees at the food
establishment meet the condition of the variance.
3. Sale of Product from Molluscan Shellfish Life Support System Display Tanks
Minnesota Rules 4626.0610 B states that Molluscan shellfish life support tanks used to store and display
shellfish that are offered for human consumption shall be operated and maintained according to a variance
granted by the regulatory authority with a HACCP plan that:
1.
water used with fish other than molluscan shellfish does not flow into the molluscan tank,
2.
the safety and quality of the shellfish as they were received are not compromised by use of the tank,
AND
3.
the identity of the source of the shellstock is retained as specified in 4626.0220 (see requirements as
stated above)
The Minnesota Food Code has specific requirements for Variances requests. The appendix at the back of
this publication provides the rule language - see parts 4626.1690 through 4626.1715. Contact the
Dairy and Food Inspection Division for more information on applying for a variance.
4-4
Reduced Oxygen Packaging
REDUCED OXYGEN PACKAGING (ROP) is defined as any packaging procedure that results in a reduced
oxygen level in a sealed packaged. You may be more familiar with the term ‘vacuum packaging’ which is one
type of reduced oxygen packaging method. Another term used is ‘Modified Atmosphere Packaging”, this is a
process that uses a gas flushing and sealing process in a one time modification of the atmospheric contents of the
package.
If reduced oxygen packaging is one of the processes that are included in your HACCP plan, the Minnesota Food
Code requires that additional information be included. These items can be included in the formal HACCP plan
or as separate documents.
Reduced Oxygen Packaging Criteria
Minnesota Rules 4626.0420 - (3-502.12)
The HACCP plan shall:
1.
Identify the food to be packaged.
This information was collected in Preliminary Steps – Number 2. See page 1-5 for more information.
If adequate detail was provided on this list, this requirement will have been met. Specific brand names
of products would not need to be included as long as the products meet the requirements as listed in
number 2 below. Be sure that this list is included as one of the documents in your official HACCP plan.
2.
Limit the food to be packaged to a food that does not support the growth of Clostridium botulinum
because the food:
a. has a water activity of 0.91 or less
b. has a pH of 4.6 or less
c. is a food with a high level of competing organisms, including raw meat, raw poultry, or a
naturally cultured standardized cheese, OR
d. is a meat or poultry product that is
i.
cured at a state inspected or USDA inspected meat facility and received in an intact
package, or
ii. cured using approved substances (nitrates/nitrites)
The MN Food code limits the types of foods that can be packaged by a reduced oxygen method at the retail
level. A store’s HACCP plan must clearly state the foods that can be packaged using a reduced oxygen
packaging method. Only specific products on this list can be reduced oxygen packaged. By limiting the types
of food that can be Reduced Oxygen Packaged to those on the list, an additional barrier to the growth and
toxin formation of Clostridium botulinum is provided and thereby helps to ensure a safe product.
In addition, except for fish that is frozen before, during, and after packaging, a food establishment shall not
package fish using a reduced oxygen packaging method.
4-5
The following are examples of foods that DO NOT meet the above requirements and therefore
MAY NOT be reduced oxygen packaged:
3.
•
Cooked turkey (including whole or sliced turkey breast)
•
Cooked roast beef
•
Sandwich spread (including ham salad, chicken salad, etc.)
•
Cooked fresh sausage (not cured/smoked such as bratwurst)
•
Raw or smoked fish
•
Processed salads (such as potato salad, cole slaw).
Specify how the food will be maintained at 41°F or below.
Maintaining the food at a temperature of 41°F or less is the primary barrier to the growth of Clostridium
botulinum. Because temperature maintenance is such a vital factor to ensuring food safety, the method for
ensuring this must be addressed in the HACCP plan.
4.
Describe how the food will be prominently and conspicuously labeled on the principal display panel in
bold type on a contrasting background with instructions to:
a. Keep Refrigerated or Frozen
b. Discard the food if within 14 calendar days of its packaging it is not served (if for on premise
consumption) or consumed (if served or sold for off premise consumption)
In addition to the normal mandatory labeling requirements, ROP foods must be labeled to include the
above statements. These statements might be included on the same label with the other information or
may be add-on stickers. As stated, these statements must be on the principal display panel (generally the
front of the package) and must be conspicuous so that the consumer is readily made aware of these special
requirements. For more information on mandatory labeling requirements, contact the Dairy and Food
Inspection Division. Be sure that these labeling requirements are addressed in the HACCP plan as part of
standard operating procedures.
The following is
an example of the
label with the
required information:
4-6
5.
Limit the shelf life to no more than 14 days from packaging to consumption, or the original
manufacturer’s “sell by” or “use by” date, whichever occurs first, unless a variance has been granted.
Pathogens, including Listeria monocytogenes may be a hazard even at refrigeration temperatures.
Therefore, it is necessary to limit the shelf life of ROP products. Ensure that this is addressed in the HACCP
plan.
6.
Include operational procedures that:
a. Comply with part 4626.0225 relating to contamination from hands.
This section of the MN Food Code discusses handwashing and direct hand contact with food. The
entire rule reference is listed in the appendix. Directionto employees must be provided as part of the
operating procedures.
b. Identify a designated area and the method by which:
i.
Physical barriers or methods of separation of raw foods and ready to eat foods minimize
cross contamination; and
ii. Access to the processing equipment is restricted to responsible trained personnel familiar
with the potential hazards of the operation
As with any food processing operation, contamination between raw and ready to eat food
can potentially create a serious food safety hazard. In addition, untrained personnel might
contribute to hazardous food handling practices or the packaging of unapproved foods. Be sure
operating procedures address these potential food safety hazards.
c. Delineate cleaning and sanitization procedures for food contact surfaces.
Properly cleaned and sanitized food contact surfaces are critical to ensuring a safe, sanitary
operation. Use of approved cleaners and sanitizers will reduce levels of pathogenic organisms
to prevent cross contamination of the product. Ensure that a complete, detailed operating
procedure for cleaning and sanitizing is included in the HACCP plan.
7.
Describe the training program that ensures that the individual responsible for the reduced oxygen
packaging operation understands the :
a. Concepts required for a safe operation
b. Equipment and facilities; and
c. Procedures specified in sub-item 6 and Standard Operating Procedures for the HACCP plan.
A training program for employees conducting ROP operations is essential to producing a safe product.
Areas to be included might be – limiting foods to be packaged, temperature control, separation of raw and
ready to eat, employee health and hygiene. A thorough understanding of how equipment operates, product
flow as well as the standard operating procedures for the facility will also add to product safety. Ensure that
these items are addressed.
4-7
5
Section
Sample Forms
5-1
HACCP Team
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Team Members
Role
Developed by: ____________________________________ Date _____________________________
5-2
Product/Process Covered
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Covered Under the HACCP Plan
Smoking/Curing
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Reduced Oxygen Packaging
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Food Additives
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Variances
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Developed by: ____________________________________ Date _____________________________
5-3
Ingredients and Raw Materials
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Category _____________________________________________________________________
Product Examples ___________________________________________________________________________
Meat Poultry and Byproducts
Nonmeat Food Ingredients
Binders/Extenders
Spices/Flavorings
Restricted Ingredients
Preservatives/Acidifiers
Liquid
Packaging Materials
Other
Developed by: ____________________________________ Date _____________________________
5-4
Process Flow Diagram
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Name _______________________________________________________________________
Flow Diagram
Developed by: ____________________________________ Date _____________________________
Verified by: _______________________________________ Date _____________________________
5-5
Equipment List
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Process ____________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Developed by: ____________________________________ Date _____________________________
5-6
Identifiying Critical Control Points
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Process/Step ________________________________________________________________________________
Critical Control Point Decision Tree
Question 1A
Do preventative measures exist for the identified hazards?
If no - go to Question 1B.
If yes - go to Question 2.
Question 1B
Is control at this step necessary for safety?
If no - not a CCP
If yes - modify step, process or product
and return to Question 1.
Question 2
Does this step eliminate or reduce the likely
occurence of a hazard(s) to an acceptable level?
If no - go to Question 3.
If yes - CCP.
Question 3
Could contamination with identified hazard(s)
occur in excess of acceptable levels or could
these increase to unacceptable levels?
If no - not a CCP.
If yes - go to Question 4.
Question 4
Will a subsequent step eliminate the identified
hazards or reduce the likely occurence to an
unacceptable level?
If no - CCP.
If yes - not a CCP.
BIOLOGICAL
T CCP#______________
T Not a CCP
CHEMICAL
T CCP#______________
T Not a CCP
PHYSICAL
T CCP#______________
T Not a CCP
Developed by: ____________________________________ Date _____________________________
5-7
Critical Limits
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Name _______________________________________________________________________
Process Step/CCP ___________________________________________________________________________
CRITICAL LIMITS
Limit (time, temp, pH, etc.) - _____________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Source (cite a regulation, scientific document, other resource) - ________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Developed by: ____________________________________ Date _____________________________
5-8
Monitoring Procedures
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Name _______________________________________________________________________
Process Step/CCP ___________________________________________________________________________
MONITORING PROCEDURES
(Who, What, When, How) - ______________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Developed by: ____________________________________ Date _____________________________
5-9
Corrective Action Procedures
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Name _______________________________________________________________________
Process Step/CCP ___________________________________________________________________________
Problem (critical limit exceeded) - _____________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
Disposition of Product (hold, rework, condemn) - ________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
Corrective Action Procedure/Steps - ____________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
Who is responsible for performing these corrective actions?- _______________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
Compliance Procedures- _____________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
___________________________________________________________________________________________
Developed by: ____________________________________ Date _____________________________
5-10
Recordkeeping Procedures
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Name _______________________________________________________________________
RECORDS
Name and Location
Developed by: ____________________________________ Date _____________________________
5-11
Verification Procedures
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process Name _______________________________________________________________________
VERIFICATION PROCEDURES
(Who, What, When, How) - ______________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
Developed by: ____________________________________ Date _____________________________
5-12
Store Name ______________________________________________________________________
Street Address ____________________________________________________________________
City ____________________________________ State ____________Zip Code ______________
5-13
Hazard Analysis Worksheet
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
(1)
Ingredient/
processing step
(2)
Identify potential
hazards
introdced,
controlled or
enhanced at this
time
(3)
Are any
potential food
safety hazards
significant?
(YES/NO)
(4)
Justify your
decision for
column 3
(5)
What preventative
measure(s)
can be applied
to prevent the
significant
hazards?
(6)
Is this step a
critical control
point?
(YES/NO)
BIOLOGICAL
CHEMICAL
PHYSICAL
BIOLOGICAL
CHEMICAL
PHYSICAL
BIOLOGICAL
CHEMICAL
PHYSICAL
BIOLOGICAL
CHEMICAL
PHYSICAL
BIOLOGICAL
CHEMICAL
PHYSICAL
BIOLOGICAL
CHEMICAL
PHYSICAL
Developed by: ____________________________________ Date _____________________________
5-14
HACCP Plan
Store Name ________________________________________________________________________________
Street Address ______________________________________________________________________________
City ____________________________________ State ____________Zip Code _______________________
Product/Process ______________________________________________ Date _______________________
(1)
Critical
Control
Poin
(CCP)
(2)
Significant
Hazards
(3)
Critical Limits
for each
Preventative
Measure
(4)
(5)
(6)
(7)
Monitoring
What
How
Frequency
(8)
Corrective
Action(s)
(9)
(10)
Records
Verification
Who
5-15
5-16
CCP
Hazard
Critical Limits
What
How
Frequency
Monitoring
Who
Corrective
Action(s)
Verification
Records
Product/Process ______________________________________________ Developed by _____________________Date __________________________
Store Name _________________________________________________Store Address____________________________________________________
HACCP Plan
Appendix
Uniform Minnesota Food Code and Common Foodborne Bacterial Pathogens
Sample Plan
Uniform Minnesota Food Code, Chapter 4626 HACCP References
DEFINITIONS
4626.0020
Subp. 40. HACCP plan, “HACCP plan” means a written document that delineates the formal procedures for following
the hazard analysis critical control point principles developed by the National Advisory Committee on Microbiological
Criteria for Foods.
4626.0030 2-102.11 DEMONSTRATION.*
Based on the risks of forborne illness inherent to the food operation, during inspections and upon request by the
regulatory authority, the person in charge shall demonstrate to the regulatory authority knowledge of foodborne disease
prevention, application of the hazard analysis critical control point principles when a HACCP plan is required under
part 4626.1730, and the requirements of the Code. The areas of knowledge are:
M. Identifying critical control points in the operation from purchasing through sale or service that may
contribute to foodborne illness and explaining steps taken to ensure that the points are controlled when a
HACCP plan is required by part 4626.1_730;
N.
explaining the details of how the person in charge and food employees comply with the HACCP plan if a
plan is required.
4626.0220 3-203.12 SHELLSTOCK; MAINTAINING IDENTIFICATION.*
A.
Except as specified in item B, sub item (2), shellstock tags shall remain attached to the container in which
the shellstock are received until the container is empty.
B.
The identity of the source of shellstock that are sold or served shall be maintained by retaining shellstock
tags or labels-for 90 calendar days from the date the container is emptied by:
(1) using an approved recordkeeping system that keeps the tags or labels in chronological order correlated to
the date when, or dates during which, the shellstock are sold or served; and
(2) if shellstock are removed from their tagged or labeled container:
(a) using only one tagged or labeled container at a time; or
(b) using more than one tagged or labeled container at a time and obtaining a variance from the regulatory
authority as specified in parts 4626.1690 to 4626.171 5 based on a HACCP plan developed according
to parts 4626.1 730 and 4626.1 735 that:
i. is submitted by the licensee and approved by the regulatory authority as specified in parts 4626.1690
to 4626.1 71 5;
ii. preserves source identification by using a recordkeeping system specified in sub item (1); and
iii. ensures that shellstock from one tagged or labeled container are not commingled with shellstock
from another container before being ordered by the consumer.
i
DESTROYING ORGANISMS
4626.0340 3-401.11 RAW ANIMAL FOODS.*
A.
Except as specified in items B and C, raw animal foods, including eggs, fish, poultry, meat, and foods
containing these raw animal foods, shall be cooked to heat all parts of the food to a temperature and for a
time that complies with one of the following methods based on the food that is being cooked:
(1) 63°C (145°F) or above for 15 seconds for:
(a) raw shell eggs that are broken and prepared in response to a consumer’s order and for immediate
service; and
(b) except as specified in sub items (2) and (3) and item B, fish and meat including game animals
commercially raised for food as specified in part 4626.0160;
(2) 68°C (155°F) or above for 15 seconds or the temperature specified in the following chart that
corresponds to the holding time for pork; ratites; injected meats; the following if they are comminuted:
fish, meat, and game animals commercially raised for food as specified in part 4626.0160; and raw eggs
that are not prepared as specified in sub item (1), unit (a):
Minimum Temperature ° C (° F)
Time
63 (145)
66 (150)
3 minutes
1 minute
(3) 74° C (165°F) or above for 15 seconds for poultry; wild game animals specified in part 4626.0160;
stuffed fish; stuffed meat; stuffed pasta; stuffed poultry; stuffed ratites; or stuffing containing fish, meat,
poultry, or ratites.
B.
Whole beef roasts and corned beef roasts shall be cooked:
(1) In an oven that is preheated to the temperature specified for the roast’s weight in the following chart and
that is held at that temperature:
Oven Temperature Based on Roast Weight
less than 4.5 kg (10 lbs)
4.5 kg (10 lbs) or more
Oven Type
Still Dry
Convection
High Humidity1
177oC (350oF) or more
163oC (325o F) or more
121oC (250o F) or less
121oC (250oF) or more
121oC (250oF) or more
121o C (250o F) or less
1
Relative humidity greater than 90 percent for at least one hour as measured in the cooking chamber or exit of
the oven-, or in a moisture-impermeable bag that provides 100 percent humidity.
(2) As specified in the following chart, to heat all parts of the food to a temperature and for the holding time
that corresponds to that temperature:
1
ii
Temperature ° C (° F)
Time1 in Minutes
54 (130)
56 (132)
57 (134)
58 (136)
59 (138)
60 (140)
61 (142)
62 (144)
63 (145)
121
77
47
32
19
12
8
5
3
Holding time may include postoven heat rise.
C.
Items A and B do not apply if:
(1) The food is a raw animal food, including raw egg, raw fish, raw-marinated fish, raw molluscan shellfish,
steak tartare, or a partially cooked food including lightly cooked fish, rare meat, and soft cooked eggs
that is served or offered for sale in a ready-to-eat form, when the food is prepared in that fashion at the
request of the consumer; or
(2) The regulatory authority grants a variance from item A or B as specified in part 4626.1695, based on a
HACCP plan that:
(a) is submitted by the licensee and approved as specified in part 4626.1695;
(b) documents scientific data or other information showing that a lesser time and temperature regimen
results in a safe food; and
(c) verifies that equipment and procedures for food preparation and training of food employees at the
food establishment meet the conditions of the variance.
4626.0415 3-502.11 SPECIALIZED PROCESSING HACCP REQUIREMENTS.*
A HACCP plan shall be prepared by a food establishment before:
A.
smoking or curing food, except for smoking done for the purpose of imparting flavor only and not as a part
of the cooking process;
B.
using food additives or adding components, including vinegar, to:
(1) preserve food rather than to enhance flavor; or
(2) render a food so that it is not potentially hazardous; or
C. using a reduced oxygen method of packaging food.
4626.0420 3-502.12 REDUCED OXYGEN PACKAGING; CRITERIA.*
A.
A food establishment that packages potentially hazardous food using a reduced oxygen packaging method
shall have a HACCP plan that contains the information specified in part 4626.1735, item A, sub item (4).
B.
A HACCP plan under item A shall:
(1) identify the food to be packaged;
(2) limit the food packaged to a food that does not support the growth of Clostridium botulinum because
the food:
(a) has an Aw of 0.91 or less;
(b) has a pH of 4.6 or less;
(c) is a food with a high level of competing organisms, including raw meat, raw poultry, or a naturally
cultured standardized cheese; or
(d) is a meat or poultry product:
i. cured at a food processing plant regulated by the United States Department of Agriculture and
received at the food establishment in intact package; or
ii. cured using substances specified in Code of Federal Regulations, title 9, sections 318.7 and
381.147;
(3) specify how the food will be maintained at 5°C (41°F) or below;
(4) describe how the packages will be prominently and conspicuously labeled on the principal display
panel: In bold type on a contrasting background, with instructions to:
(a) keep refrigerated or frozen; and
(b) discard the food if within 14 calendar days of its packaging it is not served for on-premises
consumption, or consumed if served or sold for off-premises consumption unless a variance,
including a HACCP plan, has been granted by the regulatory authority under parts 4626.1690 to
4626.1715;
iii
(5) limit the shelf life to no more than 14 calendar days from packaging to consumption or the original
manufacturer’s “sell by” or “use by” date, whichever occurs first, unless a variance, including a HACCP
plan, has been granted under parts 4626.1690 to 4626.1715;
(6) include operational procedures that:
(a) comply with part 4626.0225 relating to contamination from hands;
(b) identify a designated area and the method by which:
i. physical barriers or methods of separation of raw foods and ready-to-eat foods minimize cross
contamination; and
ii. access to the processing equipment is restricted to responsible trained personnel familiar with the
potential hazards of the operation; and
(c) delineate cleaning and sanitization procedures for food-contact surfaces; and
(7) describe the training program that ensures that the individual responsible for the reduced oxygen
packaging operation understands the:
(a) concepts required for a safe operation;
(b) equipment and facilities; and
(c) procedures specified in sub item (6) and part 4626.1735, item A, sub item (3).
C.
Except for fish that is frozen before, during, and after packaging, a food establishment shall not package fish
using a reduced oxygen packaging method.
D.
If a variance from item B, sub item (2), is requested according to parts 4626.1690 to 4626.1715, the
variance request shall include a HACCP plan.
4626.0610 4-204.1 1 0 MOLLUSCAN SHELLFISH TANKS.
A.
Except as specified in item B, molluscan shellfish life support system display tanks shall be used only to
display shellfish that are not offered for human consumption and shall be conspicuously marked so that it is
obvious to the consumer that the shellfish are for display only.
B.
Molluscan shellfish life support system display tanks used to store and display shellfish that are offered for
human consumption shall be operated and maintained according to a variance granted by the regulatory
authority as specified in parts 4626.1690 to 4626.1715, with a HACCP plan as required in parts 4626.1730
and 4626.1735 that:
(1) is submitted by the licensee and approved by the regulatory authority as specified in parts 4626.1 690 to
4626.171 5; and
(2) ensures that:
(a) water used with fish other than molluscan shellfish does not flow into the molluscan tank;
(b) the safety and quality of the shellfish as they were received are not compromised by use of the tank;
and
(c) the identity of the source of the shellstock is retained as specified in part 4626.0220.
626.1690 8-103.10 VARIANCE REQUEST; PROCEDURES.
Pursuant to Minnesota Statutes, section 14.05, subdivision 4, a party may ask the regulatory authority to grant a variance
from the provisions of the Code according to parts 4626.1690 to 4626.1715.
A.
A variance shall not be requested nor shall one be granted from:
(1) part 4626.0020, subpart 35;
(2) parts 4626.0040 to 4626.0060;
(3) parts 4626.0065 to 4626.0100;
(4) parts 4626.0105 to 4626.0120;
iv
(5) part 4626.1565;
(6) parts 4626.1590 and 4626.1595; and
(7) parts 4626.1600 to 4626.1675.
B.
The applicant for a variance shall be the party to whom the rule applies.
C.
The party requesting the variance shall submit the request in writing to the regulatory authority with the
appropriate fee, if required. A request shall contain:
(1 ) the specified language in the rule or rules from which the variance is requested;
(2) the reasons why the rule cannot be met;
(3) the alternative measures that will be taken to ensure a comparable degree of protection to health or the
environment if a variance is granted;
(4) the length of time for which the variance is requested;
(5) a statement that the party applying for the variance will comply with the terms of the variance, if
granted; and
(6) other relevant information the regulatory authority determines necessary to properly evaluate the
request for the variance.
4626.1695 CRITERIA FOR DECISION. *
The regulatory authority may grant a variance if:
A.
The variance was requested in the manner prescribed in part 4626.1690;
B.
The variance will have no potential adverse effect on public health, safety, or the environment;
C.
The alternative measures to be taken, if any, are equivalent to or superior to those prescribed;
D.
Strict compliance with the rule will impose an undue burden on the applicant;
E.
The variance does not vary a statutory standard or preempt federal law or rule; and
F.
The variance has only future effect.
4626.1700 8-103.12 CONDITIONS; HACCP; NOTIFICATION OF DECISION. *
A.
In granting a variance, the regulatory authority may attach conditions that the regulatory authority
determines are needed to protect the public health, safety, or the environment.
B.
If a HACCP plan is required to verify that the variance provides protection to the public health, safety, and
environment that is equivalent to or superior to those prescribed in rule or law, the licensee shall:
(1) comply with the HACCP plan and procedures submitted and approved as the basis for the variance; and
(2) maintain and provide to the regulatory authority, on request, the records specified in part 4626.1735,
item A, sub items (3) and (4), that demonstrate that the following are routinely employed:
(a) procedures for monitoring critical control points;
(b) monitoring of the critical control points;
(c) verification of the effectiveness of an operation or process; and
(d) necessary corrective actions if there is failure at a critical control point.
C.
The regulatory authority shall notify the party in writing of the regulatory authority’s decision to grant or
deny the variance.
(1 ) If a variance is granted, the notification shall specify the period of time for which the variance shall be
effective and the alternative measures or conditions, if any, the applicant shall meet.
(2) If a variance is denied, the regulatory authority shall specify the reasons for the denial.
v
4626.1705 8-103.13 EFFECT OF ALTERNATIVE MEASURES OR CONDITIONS.
A.
Alternative measures or conditions attached to a variance have the force and effect of law.
B.
If a party violates alternative measures or conditions attached to a variance, the party is subject to the
enforcement actions and penalties provided in law or rule.
C.
A party to whom a variance has been issued shall notify the regulatory authority in writing within 30 days of
a material change in the conditions upon which the variance was granted.
4626.1710 RENEWAL OF VARIANCE. *
A.
A request for the renewal of a variance shall be submitted to the regulatory authority in writing 30 days
before its expiration date.
B.
Renewal requests shall contain the information specified in part 4626.1690.
C.
The regulatory authority shall renew a variance if the party continues to satisfy the criteria specified in part
4626.1695 and demonstrates compliance with the alternative measures or conditions imposed at the time the
original variance was approved.
D.
This part does not apply if there has been a material change in the conditions upon which the variance was granted.
4626.1715 DENIAL, REVOCATION, OR REFUSAL-TO RENEW; APPEALS.
A.
The regulatory authority shall deny, revoke, or refuse to renew a variance if the regulatory authority
determines that the criteria in part 4626.1695 or the conditions in part 4626.1700 are not met.
B.
A party may appeal the denial, revocation, or refusal to renew a variance by requesting, in writing, a
contested case hearing under the Administrative Procedures Act, Minnesota Statutes, chapter 14, within 30
days of receipt of the notice of denial, revocation, or refusal to renew the variance.
4626.1730 8-201.13 WHEN A HACCP PLAN IS REQUIRED.
Subpart 1. Types of activities that require a HACCP plan,
The following activities require a license applicant or licensee to prepare a HACCP plan:
A.
Cooking raw animal foods under part 4626.0340, item C, sub item (2);
B.
Specialized processing under part 4626.0415;
C.
Operating and maintaining molluscan shellfish tanks under part 4626.061 0, item B;
D.
Removing tags or labels from shellstock under part 4626.0220, item B, sub item (2); and
E.
Reduced oxygen packaging under part 4626.0420.
Subp. 2. Timing of HACCP plan requirements.
A.
As of January 26, 2000, food establishments engaged in activities requiring a HACCP plan under subpart 1
must have a HACCP plan available on-site for review and verification by the regulatory authority.
B.
For new food establishments or those extensively remodeled after July 1, 1999, a HACCP plan shall be
submitted to the regulatory authority before the start of operation for approval in conjunction with the plan
review required in part 4626.1720.
Subp. 3. Compliance with HACCP plan. A licensee shall:
A.
Comply with a properly prepared and approved, if applicable under subpart 2, item B, HACCP plan; and;
B.
Maintain and provide to the regulatory authority, on request, the records specified in part 4626.1735, item A,
sub items (3) and (4), that demonstrate that the following are routinely employed:
(1) Procedures for monitoring critical control points;
(2) Monitoring of the critical control points;
(3) Verification of the effectiveness of an operation or process; and
(4) Necessary corrective actions if there is failure at a critical control point.
vi
4626.1735 8-201.14 CONTENTS OF HACCP PLAN.
A.
For a food establishment that is required in part 4626.1730, subpart 1, items A to D, to have a HACCP plan,
the plan and specifications shall include:
(1) A categorization of the types of potentially hazardous foods that are specified in the menu, including
soups and sauces, salads, meat roasts or other bulk, solid foods, or other foods that are specified by the
regulatory authority;
(2) A flow diagram by specific food or category type identifying critical control points and providing
information on the following:
(a) ingredients, materials, and equipment used in the preparation of a food; and
(b) formulations or recipes that delineate methods and procedural control measures that address the
food safety concerns involved;
(3) A statement of standard operating procedures for the plan under consideration including clearly
identifying:
(a) each critical control point;
(b) the critical limits for each critical control point;
(c) the method and frequency for monitoring and controlling each critical control point by the food
employee designated by the person in charge;
(d) the method and frequency for the person in charge to routinely verify that the food employee is
following standard operating procedures and monitoring critical control points;
(e) action to be taken by the person in charge if the critical limits for each critical control point are not
met; and
(f) records to be maintained by the person in charge to demonstrate that the HACCP plan is properly
operated and managed; and(4) Additional scientific data or other information, as required by the
regulatory authority, supporting the determination that food safety is not compromised by the
proposal.
B.
For a food establishment that is required in part 4626.1730, subpart 1, item E, to have a HACCP plan, the
plan must be prepared as specified under part 4626.0420.
vii
Common Foodborne
Bacterial Pathogens
Bacillus cereus
Campylobacter
Bacillus cereus is an aerobic spore farmer. Two types
of toxins can be produced, one results in diarrheal
syndrome and the other in emetic syndrome.
Campylobacter jejuni infection, called
Campylobacteriosis, causes diarrhea, which may
be watery or sticky and maintain blood. Estimated
numbers of cases of campylobacteriosis exceed 24 million per year, is considered the leading cause
of human diarrheal illness in the United States, and
is reported to cause more disease than Shigella and
Salmonella spp. combined.
RESERVOIR
. .WIDELY DISTRIBUTED IN THE
ENVIRONMENT.
IMPLICATED
FOODS . . . . . . .RICE, MEATS, DAIRY PRODUCTS,
VEGETABLES, FISH, PASTA, SAUCES, PUDDINGS, SOUPS,
PASTRIES AND SALADS.
B. cereus is widely distributed throughout the
environment. It has been isolated from a variety of
foods, meats, dairy products, vegetables, fish and rice.
The bacteria can be found in starchy foods such as
potato, pasta and cheese products, and food mixtures
such as sauces, puddings, soups, casseroles, pastries and
salads.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . 39-131
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.92
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.3-9.3
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . . 18
ATMOSPHERE . . . . . . . . . . . . . . . . . . . . AEROBE
SURVIVAL CONDITIONS . . . SALT-TOLERANT,
SPORES ARE HEAT RESISTANT
This organism will grow at temperatures as low as 39oF,
at a pH as low as 4.3, and at salt concentrations as high
as 18%. Unlike other pathogens, it is an aerobe, and
will grow only in the presence of oxygen. Both the
spores and the emetic toxin are heat-resistant.
CONTROLS .
viii
.......
REFRIGERATION
CONTROL OF BACILLUS CEREUS
CAN BE ACHIEVED THROUGH
PROPER REFRIGERATION.
RESERVOIR .
IMPLICATED
FOODS . . . . .
. .CHICKENS, COWS, FLIES, CATS, PUPPIES
. .RAW OR UNDERCOOKED CHICKEN,
MEAT, SEAFOOD, CLAMS, MILK,
EGGS, NON-CHLORINATED WATER,
RECONTAMINATED READY-TO-EAT
FOODS.
Raw and undercooked chicken, raw and improperly
pasteurized milk, raw clams, and non-chlorinated
water have been implicated in campylobacteriosis The
organism has been isolated from crabmeat. It’s carried
by healthy chickens and cows, and can be isolated from
flies, cats and puppies.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . .86-113
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.99
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.39-9.5
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . 1.5
ATMOSPHERE . . . . . . . . . . . . .MICROAEROPHILIC
SURVIVAL CONDITIONS . . . SENSITIVE TO DRYING,
HEATING, DISINFECTION, ACID, AIR
The thing that makes “Campy” unique is its very
special oxygen requirements. It’s micro-aerophilic,
which means it requires reduced levels of oxygen to
grow: about 3-15% oxygen (conditions similar to the
intestinal tract). Another point worth noting is that it
will not grow at temperatures below 86oF, or at salt
levels above 1.5%. The organism is considered fragile
and sensitive to environmental stresses like drying,
heating, disinfection, acid and air which is 21% oxygen.
It requires a high water activity and fairly neutral pH for
growth.
CONTROLS:
.......
SANITATION TO PREVENT
RECONTAMINATION; COOKING;
PASTEURIZATION; WATER
TREATMENT.
The controls are very basic: proper cooking and
pasteurization, proper hygienic practices by food
handlers to prevent recontamination, and adequate water
treatment.
Clostridium botulinum
Clostridium botulinum is an anaerobic spore-former.
Actually there are seven types of Clostridium
botulinum - A, B, C, D, E, F and G - but the only
ones we’ll discuss here are type A, which represents a
group of proteolytic bot, type E, which represents the
nonproteolytic group. The reason for the distinction
is in the proteolytic organisms’ ability to break down
protein.
This organism is one of the most lethal pathogens
covered here. Symptoms include weakness and vertigo,
followed by double vision and progressive difficulty
in speaking, breathing and swallowing. There may
also be abdominal distention and constipation. The
toxin eventually causes paralysis, which progresses
symmetrically downward, starting with the eyes
and face, and proceeding to the throat, chest, and
extremities. When the diaphragm and chest muscles
become involved, respiration is inhibited, and death
from asphyxia results. Treatment includes early
administration of antitoxin and mechanical breathing
assistance. Mortality is high - without the antitoxin,
death is almost certain.
RESERVOIR
. . .SOIL;FRESH WATER AND MARINE
SEDIMENTS; FISH; MAMMALS
IMPLICATED
FOODS: . . . .
. .CANNED FOODS; ACIDIFIED FOODS;
SMOKED AND UNEVISCERATED FISH;
STUFFED EGGPLANT; GARLIC IN OIL;
BAKED POTATOES; SAUTEED ONIONS;
BLACK BEAN DIP; MEAT PRODUCTS;
MARSCAPONE CHEESE.
Bot is widely distributed in nature and can be found in
soils, sediments from streams, lakes and coastal waters,
the intestinal tracts of fish and mammals, and the gills
and viscera of crabs and other shellfish. Type E is most
prevalent in fresh water and marine environments, while
Type A is generally found terrestrially.
Bot has been a problem in a wide variety of food
products: canned foods, acidified foods, smoked and
uneviscerated fish, stuffed eggplant, garlic in oil, baked
potatoes, sauteed onions, black bean dip, meat products,
and marscapone cheese, to name just a few.
Two outbreaks in the 1960’s involved vacuumpackaged fish (smoked ciscos and smoked chubs). The
causative agent in each case was C botulinum type E.
The products were packed without nitrates, with low
levels of salt, and were temperature-abused during
distribution, all of which contributed to the formation
of the toxin. There were no obvious signs of spoilage
because aerobic spoilage organisms were inhibited by
the vacuum packaging, and because type E does not
produce any offensive odors.
Three cases of botulism in NY were traced to chopped
garlic bottled in oil, which had been held at room
temperature for several months before it was opened.
Presumably, the oil created an anaerobic environment.
GROWTH REQUIREMENTS
TYPE A
TYPE E
TEMPERATURE (F) . . . . . . . . . . 50-113 . . . 38-113
MINIMUM WATER ACTIVITY . . . . 0.94 . . . . . 0.97
PH . . . . . . . . . . . . . . . . . . . . 4.6-9.0 . . . 5.0-9.0
MAXIMUM SALT (%) . . . . . . . . . 10 . . . . . . . .5
ATMOSPHERE . . . . . . . . . . . . . . . . . . ANAEROBE
SURVIVAL CONDITIONS . . . HEAT RESISTANT
Type A and type E vary in their growth requirements.
Minimum growth temperature for type A is 50oF, while
type E will tolerate conditions down to 38oF. Type A’s
minimum water activity is 0.94, and type E‘s is 0.97 - a
small difference on paper, but important in controlling
an organism. The acid-tolerance of type A is reached at
a pH of 4.6, while type E can grow at a pH of 5. A type
A is more salt-tolerant; it can handle up to 10%, when
5% is sufficient to stop the growth of type E.
Although the vegetative cells are susceptible to heat,
the spores are heat resistant and able to survive many
adverse environmental conditions. Type A and type E
differ in the heat-resistance of their spores; compared
to E, type A’s resistance is relatively high. By contrast,
the neurotoxin produced by C.bot is not resistant to
heat, and can be inactivated by heating for 10 minutes at
176oF.
CONTROLS .
.......
PREVENTION OF
TOXIN FORMATION .
.
DESTRUCTION: THERMAL
PROCESSING
ACIDIFICATION, SALT, WATER
ACTIVITY CONTROL, NITRITES,
REFRIGERATION
ix
There are two primary strategies to control C. bot.
The first is destruction of the spores by heat (thermal
processing). The second is to alter the food to inhibit
toxin production - something which can be achieved
by acidification, controlling water activity, the use of
salt and preservatives, and refrigeration. Water activity,
salt and pH can each be individually considered a full
barrier to growth, but very often these single barriers - a
pH of 4.6 or 10% salt - are not used because they result
in a product which is unacceptable to consumers. For
this reason multiple barriers are used.
One example of a product using multiple barriers is
pasteurized crabmeat stored under refrigeration; here,
type E is destroyed by the pasteurization process,
while type A is controlled by the refrigerated storage.
(Remember that type E is more sensitive to heat, while
type A’s minimum growth temperature is 50oF.)
Another example of multiple barriers is hot-smoked,
vacuum packaged fish. Vacuum packaging provides
the anaerobic environment necessary for the growth of
C. bot, even as it inhibits the normal aerobic spoilage
flora which would otherwise offer competition and give
telltale signs of spoilage. So heat is used to weaken the
spores of type E, which are then further controlled by
the use of salt, sometimes in combination with nitrites.
Finally spores of type A are controlled by refrigeration.
Vacuum-packaging of foods which are minimally
processed, like sous vide products, allows the survival
of C. bot spores while completely wiping out competing
microflora. If no control barriers are present, the C.
bot may grow and produce toxin, particularly if there is
temperature abuse. Given the frequency of temperature
abuse documented at the retail and consumer levels,
this process is safe only if temperatures are carefully
controlled to below 38oF throughout distribution.
Vacuum-packaging is also used to extend the shelf-life
of the product. Since this provides additional time for
toxin development, such food must be considered a high
risk.
x
Clostridium perfringens
Clostridium perfringens is an anaerobic spore former
and one of the most common agents of foodborne
gastroenteritis. Perfringens poisoning, the disease
caused by the organism, is characterized by intense
abdominal cramps and diarrhea.
RESERVOIR
. . .HUMANS, DOMESTIC AND WILD
ANIMALS, SOIL, SEDIMENT
IMPLICATED
FOODS . . . . .
. .MEAT, POULTRY, GRAVY, CASSEROLES
C. perfringens is widely distributed in the environment
and is frequently in the intestines of humans and many
domestic and wild animals. Spores of the organism
persist in soil and sediments.
C. perfringens has been found in beef, pork, lamb,
chicken, turkey, stews, casseroles, and gravy.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . 50-125
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.93
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.0-9.0
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . . . 7
ATMOSPHERE . . . . . . . . . . . . . . . . . ANAEROBIC
SURVIVAL CONDITIONS . . . HEAT-RESISTANT
Clostridium perfringens is a mesophilic organism.
Since it is also a spore-former, it is quite resistant to
heat, and temperatures for growth range from 50oF to
125oF. pH, water activity and salt ranges for growth are
fairly typical.
CONTROLS .
. . .PROPER COOLING, HOLDING, AND
REHEATING: EDUCATION OF FOOD
HANDLERS.
Far from killing the spores, cooking encourages them
to germinate when the product reaches a suitable
temperature. Rapid, uniform cooling after cooking
is needed. In virtually all outbreaks, the principal
cause of perfringens poisoning is failure to properly
refrigerate previously cooked foods, especially when
prepared in large portions. Proper hot holding (above
140oF) and adequate reheating of cooked, chilled foods
(to a minimum internal temperature of 165oF) are also
necessary controls. The education of food handlers
remains the critical aspect of control.
Escherichia coli
There are four classes of pathogenic E. coli;
enteropathogenic (EPEC), enterotoxigenic (ETEC),
enteroinvasive (EIEC), and enterohemmoragic (EHEC).
All four types have been associated with food and water
borne diseases.
EPEC - Gastroenteritis/infantile diarrhea - Outbreaks
have been primarily associated with infants in daycare and nursery settings.
ETCA - Traveler’s diarrhea - Contamination of water
supplies or food does occasionally lead to outbreaks.
Outbreaks have been associated with water and can
be contaminated by raw sewage and on imported
cheese.
EIEC - Bacillary dysentery - Contaminated water
supplies can directly or indirectly (by contaminating
food supplies) be the cause of outbreaks; infected
food handlers can also be a source.
EHEC - Hemorrhagic colitis - All people are believed
to be susceptible to hemorrhagic colitis. The strain
E. coli 0157:H7 has become infamous following
several outbreaks and probably countless more
unreported illnesses. Foods commonly associated
with illnesses are undercooked ground beef,
unpasteurized apple cider, raw milk, fermented
sausage, water and raw vegetables.
and proper personal hygiene, properly heated foods, and
holding foods under appropriate temperature controls.
Additionally, untreated human sewage should not be
used to fertilize vegetables and crops used for human
consumption, nor should unchlorinated water be used
for cleaning food or food contact surfaces.
Prevention of fecal contamination during the slaughter
and processing of foods of animal origin is paramount to
control foodborne infection of EHEC. Foods of animal
origin should be heated sufficiently to kill the organism.
Consumers should avoid eating raw or partially cooked
meats and poultry, and drinking unpasteurized milk or
fruit juices.
Listeria
Listeriosis, the disease caused by this organism, can
produce mild flu-like symptoms in healthy individuals.
In susceptible individuals, including pregnant women,
newborns, and the immunocompromised, the organism
may enter the blood stream, resulting in septicemia.
Ultimately listeriosis can result in meningitis,
encephalitis, spontaneous abortion and still birth.
RESERVOIR
. . .SOIL, SILAGE, OTHER ENVIRONMENTAL
SOURCES.
IMPLICATED
FOODS . . . . .
. .DAIRY PRODUCTS, VEGETABLES, MEAT,
POULTRY, FISH, COOKED READY-TO-EAT
PRODUCTS.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . 45-121
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.95
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.0-9.0
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . 6.5
ATMOSPHERE . . . . . . . FACULATIVE ANAEROBICE
SURVIVAL CONDITIONS . . .WITHSTANDS FREEZING
AND ACID ENVIRONMENTS
L. monocytogenes can be isolated from soil, silage
and other environmental sources. It can also be found
in man-made environments such as food processing
establishments. Generally speaking, however, the
drier the environment, the less likely it is to harbor this
organism.
E. coli are mesophilic organisms; they grow best
at moderate temperatures, at moderate pH, and in
conditions of high water activity. It has, however, been
shown that some E. coli strains are very tolerant of
acidic environments and freezing.
L. mono has been associated with raw or inadequately
pasteurized milk, cheeses (especially soft-ripened
types), ice cream, raw vegetables, fermented sausages,
raw and cooked poultry, raw meats, and raw and
smoked fish
CONTROLS .
L. mono is a psychotropic faculative anaerobe. It can
survive some degree of thermal processing, but can also
be destroyed by cooking to an internal temperature of
158°F for 2 minutes. It can also grow at refrigerated
temperatures below 31°F. Reportedly, it has a doubling
time of 1.5 days at 40°F. There is nothing unusual about
this organisms pH and water activity range for growth.
L. mono is salt-tolerant; it can grow in up to 10% salt,
and has been known to survive in 30% salt. It is also
nitrite-tolerant.
xi
. . .PROPER COOKING; PROPER HOLDING
TEMPERATURES; PERSONAL HYGIENE;
EDUCATION; PREVENTING FECAL
CONTAMINATION OF ANIMAL
CARCASSES.
Food may be contaminated by infected food handlers
who practice poor personal hygiene, or by contact
with water contaminated by human sewage. Control
measures to prevent food poisoning therefore include
educating food workers in safe food handling techniques
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . .31-113
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.92
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4-9.4
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . . 10
ATMOSPHERE . . . . . . . . . . FACULATIVE ANEROBE
SURVIVAL CONDITIONS . . .SALT AND NITRITE
TOLERANT
CONTROLS .
. . .COOKING, PASTEURIZATION,
Salmonella often live in animals - especially poultry
and swine - as well as in a number of environmental
sources. The organisms have been found in water,
soil and insects, on factory and kitchen surfaces, and
in animal feces. They can also survive in a variety of
foods, including raw meats and poultry, dairy products
and eggs, fish, shrimp and frog legs, yeast, coconut,
sauces and salad dressing, cake mixes, cream-filled
desserts and toppings, dried gelatin, peanut butter,
orange juice, cocoa and chocolate.
PREVENTION OF RECONTAMINATION
Prevention of recontamination after cooking is a
necessary control; even if the product has received
thermal processing adequate to inactivate L.
monocytogenes, the widespread nature of the organism
provides the opportunity for recontamination.
Furthermore, if the heat treatment has destroyed the
competing microflora, L. mono might find itself in a
suitable environment without competition.
Salmonella
There are four syndromes of human salmonellosis:
Salmonella gastroenteritis, Typhoid fever; non-typhoidal
Salmonella septicemia and asymptomatic carrier.
Salmonella gastroenteritis may be caused by any of the
Salmonella species other than Salmonella typhi, and is
usually a mild, prolonged diarrhea.
True typhoid fever is caused by infection with
Salmonella typhi. While fatality rates may exceed 10%
in untreated patients, they are less than 1% in patients
who receive proper medical treatment. Survivors may
become chronic asymptomatic carriers of Salmonella
bacteria. Such asymptomatic carriers show no
symptoms of the illness, and yet are capable of passing
the organisms to others (the classic example is Typhoid
Mary).
Non-typhoidal Salmonella septicemia may result from
infection with any of the Salmonella species and can
affect virtually all organ systems, sometimes leading to
death. Survivors may become chronic asymptomatic
carriers of Salmonella bacteria.
RESERVOIR
. . .DOMESTICATED ANIMALS AND FECES,
WATER, SOIL, INSECTS
IMPLICATED
FOODS . . . . .
xii
. .RAW MEAT, POULTRY, SEAFOOD, EGGS,
DAIRY PRODUCT, YEAST, SAUCES, SALAD
DRESSINGS, CAKE MIXES, CREAM FILLED
DESSERTS, CONFECTIONERY, ETC.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . .41-115
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.94
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.7-9.5
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . . . 8
ATMOSPHERE . . . . . . . . . FACULATIVE ANAEROBE
SURVIVAL CONDITIONS . . . SENSITIVE TO
MODERATE HEAT
Salmonella spp. are also mesophilic organisms which
grow best at moderate temperatures and pH, and under
conditions of low salt and of high water activity. They
are killed rapidly by moderate heat treatment, yet mild
heat treatment may give them the ability to develop heat
resistance up to 185oF. Similarly, the organisms can
adapt to an acidic environment.
CONTROLS
. . . .SANITATION TO PREVENT
RECONTAMINATION, COOKING,
PASTEURIZATION, PROPER HOLDING
TEMPERATURES.
Ordinary household cooking, personal hygiene to
prevent recontamination of cooked food, and control of
time and temperature are generally adequate to prevent
salmonellosis.
Shigela
There are actually four species of Shigella. Because
there is little difference in their behavior, however, they
will be discussed collectively.
Illness is Shigellosis, typical symptoms include fever,
cramps, inflammation and ulceration of intestine, and
diarrhea. This disease is easily transmitted from person
to person.
RESERVOIR .
IMPLICATED
FOODS . . . . .
. .HUMAN, ANIMAL
. .SALADS, RAW VEGETABLES, POULTRY,
MEAT, FISH, FRUIT, DAIRY PRODUCTS,
BAKERY PRODUCTS.
The only significant reservoir for Shigella is humans.
Foods associated with shigellosis include salads (potato,
tuna, shrimp, macaroni and chicken), raw vegetables,
milk and dairy products, poultry, fruits, bakery products,
hamburger and fin fish.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . .43-117
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.96
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8-9.3
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . . . 5
ATMOSPHERE . . . . . . . . . FACULATIVE ANAEROBE
SURVIVAL CONDITIONS . . . SURVIVES ACIDIC
CONDITIONS
The growth conditions for Shigella, which are
mesophilic organisms, are similar to those of
Salmonella. Shigella can survive under various
environmental conditions, including low acid.
CONTROLS
. . . .COOKING, PROPER HOLDING
TEMPERATURES, SANITATION TO
PREVENT RECONTAMINATION,
ADEQUATE WATER TREATMENT.
Shigella can spread rapidly under the crowded and
unsanitary conditions often found in such places as
summer camps, refugee camps and camps for migrant
workers, and at mass gatherings such as music festivals.
The primary reasons for the spread of Shigella in foods are
poor personal hygiene on the part of food handlers, and
the use of improper holding temperatures for contaminated
foods; conversely, the best preventive measures would be
good personal hygiene and health education. Chlorination
of water and sanitary disposal of sewage would prevent
waterborne outbreaks of shigellosis.
Staphylococcus aureus
Staphylococcus aureus produces a highly heat-stable
toxin. Staphylococal food poisoning is one of the most
economically important foodborne diseases in the US.,
costing approximately $1.5 billion each year in medical
expenses and loss of productivity. The most common
symptoms are nausea, vomiting, abdominal cramps,
diarrhea and prostration.
RESERVOIR
. . .HUMANS, ANIMALS, AIR, DUST,
SEWAGE, WATER
IMPLICATED
FOODS . . . . .
. .POULTRY, MEAT, SALADS, BAKERY
PRODUCTS, SANDWICHES, DAIRY
PRODUCTS.
Staph can be found in air, dust, sewage and water,
although humans and animals are the primary
reservoirs. Staph is present in and on the nasal
passages, throats, hair and skin of at least one out of
two healthy individuals. Food handlers are the main
source of contamination, but food equipment and the
environment itself can also be sources of the organism.
Foods associated with Staph include poultry, meat,
salads, bakery products, sandwiches and dairy products.
Due to poor hygiene and temperature abuse, a number
of outbreaks have been associated with cream-filled
pastries and salads such as egg, chicken, tuna, potato,
and macaroni.
GROWTH REQUIREMENTS
TEMPERATURE (F)
GROWTH . . . . . . . . . . . . . . . . . . . . . 45-122
TOXIN PRODUCTION . . . . . . . . . . . . . .50-118
MINIMUM WATER ACTIVITY
GROWTH . . . . . . . . . . . . . . . . . . . . . . . 0.83
TOXIN PRODUCTION . . . . . . . . . . . . . . . 0.85
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.0-10.0
MAXIMUM SALT (%)
GROWTH . . . . . . . . . . . . . . . . . . . . . . . . . 25
TOXIN PRODUCTION . . . . . . . . . . . . . . . . . 10
ATMOSPHERE . . . . . . . . FACULATIVE ANAEROBIC
SURVIVAL CONDITIONS . . . TOLERANT OF HIGH SALT
AND LOW MOISTURE
S. aureus grows and produces toxin at the lowest water
activity (0.85) of any food pathogen. And, like type
A bot and Listeria, Staph is quite salt-tolerant and will
produce toxin at 10%.
CONTROLS .
. . .HEATING, PROPER EMPLOYEE HYGIENE,
PREVENTION OF TEMPERATURE ABUSE
Foods which require considerable handling during
preparation and which are kept at slightly elevated
temperatures after preparation are frequently involved
in staphylococcal food poisoning. And, while S. aureus
does not compete well with the bacteria normally found
in raw foods, it will grow both in cooked products
and in salted products where the salt inhibits spoilage
bacteria. Since Staph is a faculative anaerobe, reduced
oxygen packaging can also give it a competitive
advantage.
The best way to control Staph is to ensure proper
employee hygiene and to minimize exposure to
uncontrolled temperatures. Remember that while the
organism can be killed by heat, the toxin cannot be
destroyed even by heating.
xiii
Vibrios
Yersinia
There are quite a few species of Vibrios, but only four
will be covered.
Yersinia ssp: Y. entercolitica; Y. pseudotuberculosis; Y. pestis
Of the 11 recognized species of Yersinia, three are know
to be potentially pathogenic to humans: enterocolitica,
pseudotuberculosis and pestis. Only enterocolitica
and pseudotuberculosis are recognized as foodborne
pathogens. Y. pestis, the organism responsible for the
black plague, is not transmitted by food.
Vibrio parahaemolyticus - The bacteria is naturally
occurring in estuaries and other coastal waters.
Illness is most commonly associated with fish
and shellfish which are raw, undercooked or
recontaminated after cooking.
Vibrio cholerae 01 - Epidemic cholera - Poor sanitation
and contaminated water supplies will spread the
disease; feces contaminated foods including seafood
have also been associated with outbreaks.
Vibrio cholerae non-01 - The reservoir for this
organism is estuarine water - illness is associated with
raw oysters, but the bacteria has also been found in
crabs.
Vibrio vulnificus - This organism also occurs naturally
in estuarine waters. So far only oysters from the Gulf
of Mexico have been implicated in illness, but the
organism itself has been found in both the Atlantic
and Pacific Oceans.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . . 41-111
MINIMUM WATER ACTIVITY . . . . . . . . . 0.94-0.97
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.8-11.0
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . 5-10
ATMOSPHERE . . . . . . . . . FACULATIVE ANAEROBE
SURVIVAL CONDITIONS . . . SALT TOLERANT; HEAT
SENSITIVE
Vibrios are mesophilic and require relatively warm
temperatures, high water activity and come neutral
pH for growth, they also require some salt for growth,
and are quite salt-tolerant. They are, however, easily
eliminated by a mild heat treatment.
CONTROLS .
. . .COOKING, PREVENTION OF
RECONTAMINATION, TIME/TEMPERATURE
ABUSE, CONTROL PRODUCT SOURCE.
All the Vibrios can be controlled through cooking and
the prevention of cross-contamination afterward. Proper
refrigeration prevents proliferation, which is particularly
important because of the short generation times for
these species. To guard against cholerae, processors
should know the source of the product and be cautious
about importing from countries experiencing an
epidemic.
xiv
Yersiniosos is often characterized by such symptoms
as gastroenteritis with diarrhea and/or vomiting, but
fever and abdominal pain are the hallmark symptoms.
Yersinia infections mimic appendicitis, which has led to
unnecessary operations.
RESERVOIR
. . .LAKES, STREAMS, VEGETATION,SOIL,
BIRDS, ANIMALS AND THEIR FECES
IMPLICATED
FOODS . . . . .
. .RAW VEGETABLES, MILK, ICE CREAM,
CAKE, PORK, SOY, SALAD, SEAFOOD,
CLAMS, SHRIMP
Yersinia can be found in raw vegetables, milk, ice cream,
cakes, pork, soy products, salads, oysters, clams and shrimp.
They are found in the environment, in such places as lakes,
streams, soil and vegetation. They’ve been isolated from
the feces of dogs, cats, goats, cattle, chincillas, mink, and
primates; in the estuarine environment, many birds - among
them, waterfowl and seagulls - may be carriers. The
foodborne nature of Yersiniosis is well established, and
numerous outbreaks have occurred worldwide.
GROWTH REQUIREMENTS
TEMPERATURE (F) . . . . . . . . . . . . . . . . . 30-108
MINIMUM WATER ACTIVITY . . . . . . . . . . . . 0.95
PH . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.2-10.0
MAXIMUM SALT (%) . . . . . . . . . . . . . . . . . . . . 7
ATMOSPHERE . . . . . . . . . FACULATIVE ANAEROBE
SURVIVAL CONDITIONS . . . WITHSTANDS FREEZING
AND THAWING; SENSITIVE TO HEATING AND SANITIZERS
CONTROLS .
. . .SANITATION TO PREVENT
RECONTAMINATION; COOKING;
PASTEURIZATION; WATER TREATMENT;
PROPER HOLDING TEMPERATURES
Key factors for controlling Yersinia include proper
cooking or pasteurization, proper food handling to
prevent recontamination, adequate water treatment,
and care taken to ensure that products are not time or
temperature abused. Proper use of sanitizers is also an
effective control. Essentially, to control Yersinia, it is
necessary to keep things clean and moving.
Sample Plans
The following represents a sample Food Safety Plan for a fictitious company. The HACCP plans have been
prepared to be in compliance with the MN Food Code. Recognizing that the HACCP plan is only part of
the food safety plan, additional supporting information is included on GMP’s and SOP’S.
The plan is composed of the following sections:
Plan for Smokehouse operations including:
- Equipment list
- Formulation/Recipe
- Flow Diagram
- Standard Operating Procedures including Critical Control Points, Critical Limits, Monitoring,
and Corrective Actions
Plan for Reduced Oxygen Packaging Operations including:
- Equipment List
- Flow Diagram
- Standard Operating Procedures including Critical Control Points, Critical Limits, Monitoring,
and Corrective Actions
Plan for ...
Also included is General information that might apply for all HACCP plans which includes:
Training Program
Standard Operating Procedures for Person in Charge
Labeling
Cleaning and Sanitizing Procedures
Good Manufacturing Practices - Employee Practices
xv
Retail Food Establishment
Food Safety Plan
Including:
HACCP PLAN
For: Smokehouse Operations
Reduced Oxygen Packaging
GMP’s/SOP’s
Employee Practices
Cleaning and Sanitizing Procedures
Verifications Procedures by Person in Charge
Labeling Requirements
Training Program
J’s Market
505 Saratoga St.
Anytown, MN
JANUARY 13, 2000
xvi
Smokehouse Operations Equipment List
Walk-in Cooler – brand _________________________________ size ____________________________
Other products/operations supported ______________________________________________________
Grinder
Mixer
Stuffer
Smokehouse- brand____________________________________________________________________
Smoke generator/liquid smoke
Digital Thermometer
Assorted measuring containers, hand utensils, lugs, totes, etc.
Smokehouse Operations Formulation/Recipe
RING BOLOGNA
Full batch
50 pounds pork trim
50 pounds beef trim 6.5 (1 full packet) pounds of XYZ brand Bologna Seasoning
4 oz (l full packet) of Quick Cure 10 pounds water
Casings - Natural beef casing
Also include procedures for producing the product that show who food safety concerns are controlled.
Recipes to be included for every product
xvii
Smokehouse Operations Flow Diagram
Receive Non-Meat
ingredients, packaging
materials
Receive Raw Meat
Storage of non-meat
ingredients, packaging
materials
Storage of Meat
Recipe Review
Mix and/or weigh out
seasonings
Weigh Out Meats
Grind Meat
Weight Out Cure
Mix/Blend meats, seasonings,
and nitrates
CCP
Stuff and Hang
Cook/Smoke
CCP
Chill/Storage
CCP
Packaging and Labeling
Reduced Oxygen Packaging
Over-wrap Packaging
See ROP Flow Chart
Cooler or Freezer Storage
Storage of Finished Product
Retail Display Case
xviii
Smokehouse Operations Standard Operating Procedures
CURED -SMOKED/COOKED SAUSAGE
1 . Receiving/Storage of meat products, seasonings, fillers, cure agents, packaging materials, sawdust. Check the
temperature of meat products on receipt. These products must be received at 41°F or less- products at higher
temperatures should be rejected. Perishable products must be stored in refrigeration at 41°F or less or frozen at
0°F or less - Ensure that all products are stored under sanitary conditions to prevent contamination.
2. Ensure that facilities are clean and sanitary and in good condition and that equipment is clean and sanitary
and is working properly and safely. Ensure that sawdust is in the smoke generator and install a temperature
recording chart on the smokehouse.
3. Ensure that food handlers are in compliance with Employee Practices requirements in the Good Manufacturing
Practices.
4. Review the recipe to confirm that all required ingredients, are on hand and assemble spices, fillers, cure agents,
casings, packaging materials, etc in the work area.
5. Establish the size of the batch to be made. Almost all pre-mix units come packaged for 100 pounds of meat.
Example:
100.00 lbs
6.50 lbs
.25 lb
10.00 lbs
meat
seasoning and filler (one bag)
cure (separate packet) RESTRICTED INGREDIENT
water
116.75 lbs
gross weight ii
If less than a full batch is to be made, calculations must be made to reduce all ingredients by the same amount.
Examples of reduced batches are:
1/2 batch
50.00 lbs
3.25 lbs
0.125 lbs
5.00 lbs
58.375 lbs
Examples of reduced batches are:
1/4 batch
25.00 lbs
1.6251b
.06251b
2.5 lbs
29.1875 lbs
meat
seasoning and filler
cure RESTRICTED INGREDIENT
water
gross weightiiiii
meat
seasoning and filler
cure RESTRICTED INGREDIENT
water
gross weightiiiii
Weigh out meat, seasonings and fillers, and water. Do not necessarily assume that containers/ pails/lugs/scoops of
ingredients always weigh the same. Record entries for these ingredients on the batch record
xix
6. Grind the meat.
7. *Critical Control Point* - Weigh out cure and premix with at least 1 pint of water to provide better
distribution with the other ingredients. Pre-mix seasonings with part of the remaining water. In the automatic
mixer, mix meat with seasoning/water blend, fillers, remaining water, and cure /water blend.
Critical Limit - For full batches (100 pounds), net weight of cure is .25 lbs; for 1/2 batch/50 pounds net
weight of cure is .125 pounds; for 1/4 batch (25 pounds) net weight of cure is .0625 pounds. Because of the
small amounts of cure required batches, weighing of cure ingredients must be done on a certified digital scale.
Thoroughly mix ingredients, especially the cure mixture to ensure even distribution throughout the batch.
Monitoring - Observe the mixing process to ensure complete distribution. Complete entries on the batch
record. Attach seasoning and cure bag to batch record.
Corrective Action - If errors are noticed before any further steps are completed, take the following steps:
- If insufficient cure has been added, additional amounts up to the amount required in the recipe can be
added and the batch re-mixed
- If too much cure was added, additional meat and seasonings can be added to extend the batch and remixed.
If errors are noted after the cook step, nothing can be done to save the batch and the entire batch must be
discarded.
8. Stuff the mixed product into the appropriate size and type of casing for the product being made. Use only
clean, fresh casings that have been stored properly to prevent contamination. Hang to product onto rods and
into smokehouse. Insert temperature probe into product into sausage.
9. *Critical Control Point* - Smoke and Cook. Set smokehouse computer to the appropriate cycle for the
product being produced. The smokehouse will automatically shut down when the programmed temperature is
reached.
Critical Limit - Minimum internal temperature of product are:
Beef and Pork - 155°F for 15 seconds
Poultry - 165°F for 15 seconds.
Monitoring - Inspect temperature chart to ensure that the highest attained temperature has been met. Record
the highest attained temperature on the Batch Record.
Corrective Action - If minimum temperature has not been met, reset the smokehouse and re-cook until the
minimum time and temperature have been met.
10. *Critical Control Point* - Cooling. The product must be rapidly cooled. This may be part of the smokehouse
cycle if the unit has an internal shower. Showering with water will assist in bringing the temperature down.
Next, the product must be removed from the smokehouse and placed in the cooler (which is at 41°F or less).
This should happen immediately after the smokehouse cycle is completed as it is important that the cooling
process begins right away. When cooked product is placed into the cooler, ensure that it is placed so that it is
protected from cross contamination by raw meat.
Critical Limit - Products must be cooled from 140°F to 70°F within 2 hours and from 70° to 41°F within
another 4 hours.
Monitoring - Check internal temperature at 1 hour and 45 minutes, at 2 hours, and again at 6 hours. Record
internal temperature on batch record .
xx
Corrective Action - If the temperature taken at 1 hour 45 minutes is at 75° For greater, notify the Person in
Charge and take immediate action to reduce the temperature. This can be accomplished by showering with cold
water or if a greater temperature reduction is necessary, product could go into a water bath. If product does not
meet the critical limits at 2 and 6 hours, it must be discarded.
11. Packaging/Labeling - if product is packaged by a Reduced Oxygen packaging method, refer to Standard
Operating Procedures for ROP. If product is packaged by over-wrapping, ensure that packaging materials
(trays, wrap) are in a sanitary condition and do not subject the food to cross contamination. Food employees
must limit direct hand contact with exposed ready to eat food. Products be labeled with mandatory labeling
requirements.
12. Storage/Display - Place packaged food into refrigerated storage, either retail display cases or cooler storage at
41°F or less.
xxi
Smokehouse Operations
J’s Market
505 Saratoga St. W
Anytown MN 55555
Batch Record
Required to be completed for each product made as official record of monitoring critical control points.
PRODUCT
_______________________PRODUCTION DATE _________
FORMULATION:
Beef:______________LBS
Pork:______________LBS
Turkey: ____________LBS
Veal: ______________LBS
CODE/LOT ID ____________
Water:____________________ LBS
Other: ____________________
____________________
____________________
Seasonings: Contents and Weight _______________________________________________
__________________________________________________________________________
__________________________________________________________________________
CURING AGENT: Critical Control Point
Type ______________Weight ______________ Signature ___________________________
How incorporated (mix, injected, soak, etc.) _______________________________________
Cure Lot Number ____________________________________________________________
Other Processing ____________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
SMOKE/COOK: Critical Control Point
Temperature Checks: _________________________________________________________
FINAL INTERNAL TEMPERATURE* _________ °F *Minimum cook temperature of 155°F
(165°F for poultry)
Signature __________________________________________________________________
COOLING: Critical Control Point
Temperature Checks _________________________________________________________
Temp at 2 Hours*__________________________________________ *Must be 70°F or less
Signature __________________________________________________________________
Temp at 6 Hours*__________________________________________ *Must be 41°F or less
Signature __________________________________________________________________
All CCP’s Met?
Yes
No
Signature _________________________________________________________________________
xxii
Reduced Oxygen Packaging
Equipment List
• Slicer - brand ______________________________________________________________________
• Vacuum Packaging Machine - _________________________________________________________
• Digital Thermometer
• Assorted knives, tongs, trays, lugs/totes, hand utensils
Flow Diagram
Storage of Perishables to be
Packaged
Storage of Packaging
Materials
Assemble products to be
packaged and packaging
materials.
Reduced Oxygen Packaging
of Foods
Check Package Integrity
Weigh and Label
Finished Product Storage
Retail Display
CCP
Cooler Storage
xxiii
Reduced Oxygen Packaging Standard Operating Procedures
Only food handlers that are trained in the use of the reduced oxygen packaging equipment and process of reduced
oxygen packaging and have a thorough understanding of the HACCP plan shall operate or conduct ROP operations.
1 . Ensure that facilities in the area where ROP operations are to be conducted are clean and sanitary and are
in good physical condition. ROP operations must only be conducted in the designated area in the meat
department. No packaging of ready to eat foods can be conducted while raw foods are present or are being
processed in the same room. Only properly cleaned and sanitized equipment is to be used in the operation.
2. Ensure that all equipment is operating properly and safely. Ensure that equipment involved in the ROP process
has been properly cleaned and sanitized according to regulation and store policy. This equipment includes (but
not limited to): tables, cutting boards, slicer, knives, tongs, trays,
3. Ensure that food handlers are in compliance with Employee Practices requirements in the Good Manufacturing
Practices. This includes employee hygiene, handwashing, clean clothing, etc.
4. Assemble packaging materials, labels, etc. necessary to the operation.
5. Assemble products that are to be packaged.
• Products to be ROP shall remain at room temperature no longer than 30 minutes during the packaging
process, therefore, only remove sufficient quantities so that this is managed.
• Products that can be ROP are limited to list provided.
6. Place foods in the packaging materials. Food Employees must limit direct hand contact with exposed, ready-toeat food when deli tissues, spatulas, tongs, dispensing equipment, or other utensils can be used.
7. Place bags in vacuum machine ensuring that adequate space is provided around each package. Ensure that
machine settings are appropriate for product being packaged. It is important that a full vacuum is provided or if
using gas displacement, that the equipment is working properly. Start the machine and wait for the lid to open
indicating that the process is complete
8. Remove packages from the machine. Visually check the seal to ensure that it is tight and that there are no food
materials in the seal. Make a note of any indicators of a faulty seal such as wrinkles or an incomplete seal.
Packages with a faulty seal should be re-packaged. Trim excess packaging as required.
9. Weigh and label each package. Ensure that all required information is provided on the label. Ensure that the
shelf life is no longer than 14 days.
10. *Critical Control Point * Place packaged food into refrigerated storage, either retail display cases or cooler
storage.
Critical Limit - Temperature in storage must be 41°F or less. Products will be considered to be temperature
abused if they are exposed to temperatures above 41°F for more than 4 hours.
Monitoring - The designated employees of the meat department will check and record the actual temperature
in both the walk-in cooler and retail case that contains in-store packaged products at intervals not to exceed 4
hours. If temperatures are out of range, notify the Person in Charge and move products to other approved
storage location that does meet temperature requirements. Record tempurature on cold storage log.
Corrective Action -Discard temperature abused products. Make necessary adjustments or repairs to cooler or
case prior to restocking. Document any corrective actions on the log.
11. Visually check ROP products on a daily basis in the retail case or as products in reserve storage are brought out
to the retail case and check the package integrity (faulty seals, ‘puffy’ packages, holes, tears, or packages that
may have otherwise lost their ‘vacuum’) and contents of the package (slime, mold, discoloration). Packages
that do not meet the requirements should be destroyed. Also check for products that have passed their’use by’
date.
xxiv
Cold Storage Log
Store Name _____________________________________________________________________________
Store Address ___________________________________________________________________________
Month/Year __________________________ Cooler/Location ____________________________________
DATE
TIME
TEMP.
S
TIME
TIME
S
DATE
1
17
2
18
3
19
4
20
5
21
6
22
7
23
8
24
9
25
10
26
11
27
12
28
13
29
14
30
15
31
TIME
TEMP.
S
TEMP.
TEMP.
S
16
S= signature of person taking/recording temperature
If air temp is more than 45°, check product temperature;
If product temp is more than 41° but less than ___°, move product to another cooler, cool to 41 ° within 4 hours and
make necessary repairs to case;
If product temperature is higher than ___°, discard product and make necessary repairs to the case
Any record noted above 41°F, must have explanation/corrective action noted below:
For example:
5/4 – temp at 45° – case on defrost – product temp - 39° - OK or
5/5 – temp at 50° – product temp 50° – 100 pounds of sausage product destroyed
Records Reviewed by: _____________________________________________Date: __________________
Comments:
xxv
Labeling
Mandatory Labeling Information
1. Name of Product
2. Name, address including zip code of store
3. Net weight statement
4. Complete and detailed ingredients statement
5. On fresh/raw meat products, the Safe Handling Statement must be included
6. Nutrition facts may be required, contact the Minnesota Department of Agriculture
In addition, Reduced Oxygen packaged food labels must also include:
1. The Statement: Keep Refrigerated or Frozen
2. Instructions to discard the food if within 14 days of its packaging if it is not consumed
3. The shelf life must not be longer than 14 days from packaging to consumption or the original manufacturers
‘sell by ‘ or’use by’ date, whichever occurs first.
Shelf life for various products will be as follows:
All in-store smikehouse products
XX days
Sliced cold cuts (ham, smoked turkey, salami, etc.)
XX days
Cheese (block or sliced)
XX days
Raw meats or poultry
XX days
Sample Label
xxvi
Training Program - For Food Handlers Conducting Reduced Oxygen Packaging
Understanding the potential hazards associated with reduced oxygen packaging.
While the process of packaging foods using a reduced oxygen method extends the shelf life, it also can pose a
serious public health threat.
Generally, bacteria survive under conditions where there is oxygen is present - aerobic conditions - or where
oxygen is not present anaerobic conditions. Some bacteria have the ability to adapt to either condition. Under
traditional packaging conditions (aerobic conditions), spoilage bacteria would normally thrive and the product
would spoil before the more hazardous types of bacteria might become a problem. During the process of ‘vacuum
packaging’ or ‘reduced oxygen packaging’, the air inside the package (which is approximately 21 % oxygen) is
eliminated, creating anaerobic conditions and thereby changing the types of bacteria that can survive in the package.
Spoilage organisms are eliminated, but several types of pathogenic bacteria survive and actually thrive under these
conditions. The pathogen of greatest concern is Clostridium botulinum. While botulism bacteria will normally
be killed in a cooking step, spores of the bacteria may survive and could grow and produce toxin if the conditions
are right. These conditions are similar to those that occur in a vacuum/reduced oxygen package. Other pathogens
of concern may be Listeria monocytogenes, Yersinia enterocolitica, Campylobacter jejuni, and Clostridium
perfringens.
xxvii
Concepts Required for a Safe Operation
A thorough understanding of the of the HACCP plan, the use of the reduced oxygen packaging equipment, and
the standard operating procedures are critical to a safe operation. Areas to focus on include: products that can be
packaged, temperature control, prevention of cross contamination, and health and personal hygiene of food handlers.
Products that can be packaged by ROP
•
State regulations limit the types of foods that can be packaged. This store’s HACCP plan defines the foods that
can be packaged using reduced oxygen packaging. Only specific products on this list can be reduced oxygen
packaged. Any addition to the above list must first have the approval of the PERSON IN CHARGE. Changes
must be noted in the HACCP PLAN. Foods to be reduced oxygen packaged at the retail level must be limited
to one that does not support the growth of Clostridium botulinum because of one of the following requirements:
1. has a water activity of 0.91 or less
2. has a pH of 4.6 or less
3. is a food with a high level of competing organisms, including raw meat, raw poultry, or a naturally
cultured standardized cheese
4. is a meat or poultry product that was cured at a USDA meat plant and received in an intact package or
cured using approved substances (nitrates/nitrites).
By limiting the types of food that can be ROP to those on the list, an additional barrier to the growth of
Clostridium botulinum is provided and thereby helps to ensure a safe product.
In addition, except for fish that is frozen before, during, and after packaging, a food establishment shall not
package fish using a reduced oxygen packaging method.
Following are examples of foods that do not meet the above requirements and therefore may NOT be reduced
oxygen packaged: Cooked turkey (including whole or sliced turkey breast), cooked roast beef, sandwich spread
(including ham salad, chicken salad, etc.), cooked fresh sausage (not cured/smoked such as bratwurst), fresh
salads.
Temperature Control
•
Temperature control is a very important factor in keeping all potentially hazardous foods safe. But the
extended shelf life and decreased oxygen concentration allows certain pathogens to multiply in reduced
oxygen conditions. To reduce the potential for growth of these pathogens, products (packaged and unpackaged) must be stored at cooler temperatures of 41o F or less. Employees must monitor the cooler
temperatures at least every 4 hours to ensure that foods are not allowed to be out of the temperature
requirements for extended periods of time.
Preventing Cross Contamination
•
Raw foods should be handled separately from cooked and ready to eat foods to avoid cross contamination.
Utensils, equipment and work surfaces used for raw foods should be thoroughly cleaned and sanitized prior to
using for cooked or ready-to-eat foods. In addition, ensure that ready-to-eat foods are stored so that blood or
juices from raw products can not drip or otherwise come into contact with them. Food handlers can also be a
source of cross contamination through improper handwashing, or soiled clothing or aprons.
Employee Health and Hygiene
• The health and personal hygiene of food handlers can also play a critical role in producing a safe ROP food.
It is vital that employees working in this operation follow the Employee Practices guidelines in the Good
Manufacturing Practices. (See Page xx). Particular attention should be paid to #1 - Handwashing procedures,
#6 Clean Outer Garments, and #1 0 - Food handling.
xxviii
Cleaning and Sanitizing Procedures - Equipment Food Contact Surfaces
Properly cleaned and sanitized food contact surfaces are critical to ensuring a safe, sanitary operation. Use of
approved cleaners and sanitizers will reduce levels of pathogenic organisms to prevent cross contamination of the
product. Detergent cleaners suspend and help remove various food soils. Chemical sanitizers (chlorine, iodine, acid,
or quaternary ammonia types) reduce the numbers of pathogens and other microorganism to insignificant levels.
The clean up process must be completed in accordance with the following procedures.
•
Pre-cleaning -equipment and utensils shall be pre-flushed, presoaked, or scraped as necessary to eliminate
excessive food debris
•
Washing - equipment and utensils shall be effectively washed to remove or completely loosen soils using
manual or mechanical means. Only approved chemicals are to be used in this process. Approved chemicals for
WASHING are: __________________________________________________________________________
•
Rinsing - washed utensils and equipment shall be rinsed to remove abrasives and to remove or dilute cleaning
chemicals with water
•
Sanitizing - After being washed and rinsed, equipment and utensils must be sanitized with an approved
chemical by immersion, manual swabbing, brushing, or pressure spraying methods. Exposure time is important
to ensure effectiveness of the chemical. Approved chemicals and exposure times for SANITIZING are:
________________________________________________________________________________________
________________________________________________________________________________________
Ensure that an appropriate chemical test kit is available and routinely used to ensure that accurate concentrations of
the sanitizing solutions are being used.
Frequency of Cleaning
Equipment, food contact surfaces and utensils shall be cleaned in a time frame as follows:
1
Before each use with a different type of raw animal food, including beef, fish, lamb, pork, or poultry;
2. Each time there is a change from working with raw foods to working with ready to eat foods;
3. Between uses with raw fruits or vegetables and with potentially hazardous foods;
4. At any time during the operation when contamination may have occurred.
5. If used with potentially hazardous foods, throughout the day at least once every four hours
6. Utensils and equipment that are used to prepare food in a refrigerated room that maintains the utensils,
equipment, and food under preparation at 41°F or less and are cleaned at least once every 24 hours
7. Before using or storing a food thermometer.
8. For equipment used for storage of packaged or un-packaged food, including coolers, and the equipment is
cleaned at a frequency necessary to eliminate soil residue.
9. For ice bins, at a frequency necessary to preclude accumulation of soil or mold.
10. Food contact surfaces of cooking equipment shall be cleaned at least once every 24 hours.
Non-food-contact surfaces of equipment shall be cleaned at a frequency necessary to prevent accumulation of soil
residues.
xxix
Good Manufacturing Practices - Employee Practices
1. Hands are to be thoroughly washed in a designated hand sink with soap and water, paying particular attention to
the areas underneath the fingernails and between the fingers by scrubbing thoroughly with a using a fingernail
brush. Dry with single use towels. Handwashing is to be done at the following times:
•
after using the toilet, in the toilet room
•
after coughing, sneezing, using a tissue, using tobacco, eating, or drinking
•
after handling soiled equipment or utensils
•
immediately before engaging in food preparation activities
•
during food preparation as necessary to remove soil and prevent cross contamination
•
when switching between raw and ready-to-eat foods
•
other times as needed to maintain good sanitation
2. Fingernails must be kept trimmed, filed, free of nail polish, and maintained so the edges are cleanable and not
rough.
3. Eating and drinking is prohibited in areas where contamination of exposed food, clean equipment, utensils,
unwrapped single service and single use articles could occur. A food employee may drink from a closed
beverage container in a food prep area as long as it is handled to prevent contamination.
4. Effective hair restraints must be worn in processing areas.
5. Smoking and other uses of tobacco are prohibited.
6. Clean outer clothing must be worn each day and changed as often as necessary throughout the day (when
moving from a raw food operation to a ready-to-eat food operation).
7. Frocks and aprons used by employees are to be hung in a designated area when not in use. They are not to be
worn in the toilet area, eating areas and locker rooms.
8. Foot wear is to be kept clean.
9. No jewelry (except a wedding band or other plain ring) is allowed during handling of food.
10. Food Employees shall report to the Person in Charge when they have a symptom caused by illness, infection, or
other source that is:
•
associated with diarrhea, vomiting or other acute gastrointestinal illness
•
jaundice
•
a boil, infected wound or other lesion containing pus that is open or draining unless:if on the hands or
wrists, unless a finger cot or other impermeable cover protects the lesion and a single use glove is worn
if on exposed portions of the arms, the lesion is protected by an impermeable cover.
The Person in Charge shall impose the proper restrictions and exclusions according to rule.
xxx
Additional Examples of Formats for HACCP Documents
Flowchart for Clam Chowder
Chowder Soup Base
(frozen)
Clams
(canned)
Vegetables
(pre-cut, washed)
RECEIVING
STORING
Store in freezer
Store in dry storage
Store in refrigerator
PREPARING
Thaw in refrigerator
COOKING
CCP • Cook all ingredients to 165oF
or higher for at least 15 seconds
SERVING AND HOLDING
CCP • Serve immediately or hold soup
at 140oF or higher
TRANSPORTING
CCP •Hold soup at 140oF or higher
for no longer than 30 minutes
COOLING
CCP • Cool soup from 140oF to 70oF in
2 hours and from 70oF to 40oF in 4 hours—or
a total cooling time of 6 hours
REHEATING
CCP • Reheat soup to 165oF or higher for at least
15 seconds within 2 hours
xxxi
Flowchart for Baked Whitefish and Vegetables
RECEIVING
•
•
•
•
Obtain whitefish from an approved source.
Receive fish well-iced, under refrigeration at 40oF (4oC) or lower.
Fish must be free of odors and visible signs of contamination.
Fresh must be free of signs of spoilage, contamination, and pest infestation.
STORING
•
•
•
•
Store raw fish below or away from ready-to-eat foods and other foods that will receive no further
cooking.
Maintain fish at an internal temperature of 40°F (4°C) or lower.
Store vegetables separate from raw, potentially hazardous foods.
Label and date products; use FIFO method of stock rotation.
PREPARING
•
•
•
Scale, clean, and fillet whole fish using cleaned and sanitized utensils and cutting board.
A Store raw fish under refrigeration at a product temperature of 40°F (4°C), or lower, until ready
for cooking.
Wash fresh vegetables and lemons, and slice using cleaned and sanitized utensils and cutting board.
COOKING
•
•
•
Preheat oven to 400°F (200°C) or higher.
Bake fish and vegetables to internal temperatures of 145°F (64°C), or higher, for at least 15
seconds.
Verify final cooking temperature with a cleaned and sanitized thermometer or thermocouple.
HOLDING AND SERVING
•
•
•
•
Serve immediately. ...OR...
Preheat hot-holding cabinet to 165°F (74°C) or higher.
Hold at 140°F (60°C), or higher, for less than 2 hours.
Discard any leftover fish fillets held more than 2 hours.
RECEIVING
•
•
•
•
Obtain cod fillets from an approved source.
Receive fish well-iced, under refrigeration at 40°F (4°C) or lower.
Fillets must be free from odors and visible signs of contamination.
Liquid pasteurized egg product must be received intact from a reputable supplier at 40°F (4°C) or
lower.
STORING
•
•
•
•
xxxii
Refrigerate raw fillets below or away from ready-to-eat foods and other foods that will receive no
further cooking.
Maintain fillets at internal product temperatures of 40°F (4°C)or lower.
Refrigerate liquid pasteurized egg product on upper shelf or separate from raw, potentially
hazardous foods.
Maintain liquid pasteurized egg product at a product temperature of 40°F (4°C) or lower.
PREPARING FISH
•
•
•
Rinse and drain fillets in a cleaned and sanitized prep sink.
Cover and refrigerate below cooked foods until breading is prepared.
Remove in small batches, and season each fillet before breading.
PREPARING BREADING
•
•
•
•
Use four cleaned and sanitized pans for breading steps.
Prepare fresh pans when a new complete recipe is needed.
Never add new breading mixture to old.
Discard leftover breading and any breading exposed to temperatures of 40°F (4°C) or higher for
more than 2 hours.
COOKING
•
•
Heat fat in deep fryer to 375°F (190°C).
Fry fish to an internal temperature of 145°F (64°C), or higher, for at least 15 seconds.
HOLDING AND SERVING
•
•
•
Serve immediately, ...OR...
Hold at 140°F (60°C) or higher for less than 2 hours,
Discard any leftover fish fillets held more than 2 hours.
xxxiii
Flow Diagram for HACCP Category: Fully Cooked, Not Shelf Stable Whole Muscle Products
Example Product(s): Hickory Smoked Bacon, Hickory Smoked Boneless Ham
Receive from Raw, Not
Ground HACCP plan
Storage of Meat
Receive Non-Meat
Ingredients
Receive Packaging
Supplies
Storage of Non-Meat
Ingredients
Storage of Packaging
Supplies
CCP 1B
Formulate Non-Meat
Ingredients
Inject/
Pump
Mix
Brine
Soak in
Cure
Tumble
Net/Stuff/
Hang/Rack
Storage of Cure Meat
Cook/Smoke
CCP 3B
Fabricate
Chill/Storage
CCP 4B
Package &
Label
Storage
CCP 5B
Retail Sales
Ship
xxxiv
CCP 2B
CCP
CP
Surviving bacterial
spores may germinate to
vegetative cells if chilling
is to slow.
Products may be
incorrectly labeled.
Outdated product may not
be safe. Economic fraud.
Cross-contamination.
CHILLING
PACKAGING AND
LABELING
CCP
CCP
Pathogens and bacterial
spores may survive if
product is not properly
cooked.
COOKING AND
SMOKING
DISPLAY
CP
Cross- contamination
between personnel and
equipment.
STUFFING AND
HANDLING
Improper temperature
may result in rapid and
progressive growth of
pathogens.
CCP
Insufficient mixing or
amounts may result in poor
distribution of cure.
MIXING
CP
STORAGE
Rapid bacterial growth and
cross- contamination.
CP
Rapid bacterial growth, spoilage,
cross- contamination,
foreign objects.
GRINDING
CP
RECEIVING
CCP/CP
Rapid bacterial
growth, spoilage,
cross- contamination,
foreign objects.
POTENTIAL
HAZARDS
Temperature must be maintained at 40°F
or below. Products will be considered
temperature-abused if they are exposed
to temperatures above 40°F for more than
six hours.
Overwrap product to prevent bacteria
growth. Policies for rotation, disposal,
and proper labeling must be followed.
Follow good manufacturing practices.
Products must be cooled to 70°F within
two hours, and to 40°F and below within
another 4 hours.
Internal temperatures must be:
Beef and Pork: 155°F
Poultry: 165°F
Utensils and equipment must be clean.
Employees must meet personal sanitary
standards.
Cure must be properly distributed,
following uniform formulation mix.
Utensils and equipment must be clean.
Employees must meet personal sanitary
standards.
Temperature at 40°F or below. Any
product stored above 70°F or a four-hour
period must be discarded.
Frozen items must be kept frozen.
Chilled items must be kept at 40°F or
below. No cross-contamination, foreign
objects or spoilage.
CRITICAL
LIMITS
Stop production and rework
product.
Re-cook product until the
minimum time and temperature
have been met.
Discard any product not cooled
to 40°F or below within six
hours.
Visual inspection.
Inspect temperature chart. Verify
that the minimum time and temperature have been met.
Record internatl temperature on
batch make slip at two hours and six
hours.
Check and record display case
temperature every four hours.
Lower the thermostat. Discard
any temperature-abused
products.
Record the lot code and refrigeration Reject or discard improper
statement. Follow proper procedures packaging. Discard outdated
for coding and dating. Follow good products.
manufacturing practices.
Modify and re-blend, following
uniform formulation mix.
Stop production and modify
procedure.
Visual inspection.
Observe batch make slip, date and
weight of product. Attach seasoning
and cure bag.
Adjust cooler temperature.
Discard any product that
exceeds 70°F for more than
four hours.
Reject thawed frozen items.
Reject chilled items above 40°F.
Reject product with foreign
objects.
CORRECTIVE
ACTIONS
Record temperature every four hours.
After normal working hours, the
cooler will be on automatic alarm
system.
Visual inspection.
Use a digital thermometer.
POTENTIAL
HAZARDS
Flow Diagram for Smoked Sausage
xxxv
xxxvi
Receive
non-meat
ingredients
Storage of
packaging
supplies
Receive
non-meat
ingredients
Receive
packaging
supplies
Receiving from
chill
Storage of meat
Receive meat
form raw, not
ground HACCP
Plan
PROCESS
STEP
P: — No
B — Yes
P— None
B — Pathogen Growth
P — Foreign Materials
No
B — Microbial Spores
No
B — Microbial Spores
P — Foreign Materials
No
P — No
P — Foreign Materials
C — None
C — No
B — No
B — Microbial Spores
C — None
No
P — Foreign Materials
C — None
No
No
P — No
C — No
B — No
P — None
P — Foreign Materials
C — None
B — Microbial Spores
(ex. overhead contamination)
P — Foreign Materials
C — Pathogen Growth
B — Pathogen Growth
(ex. overhead contamination)
C — No
C: — No
C — None
C — None
B: — No
RESEASONABLY
LIKELY TO
OCCUR
B — None
FOOD SAFETY
HAZARD
Letters of guarantee are on file for all packaging
supplies and ingredients
Letters of guarantee are on file for all packaging
supplies and ingredients
Letters of guarantee are on file for all packaging
supplies and ingredients. GMP’s, routine samition,
visual observation for container integrity.
Letters of guarantee are on file for all packaging
supplies and ingredients
Letters of guarantee are on file for all packaging
supplies and ingredients.
Letters of guarantee are on file for all packaging
supplies and ingredients.
Letters of guarantee are on file for all packaging
supplies and ingredients.
Letters of guarantee are on file for all packaging
supplies and ingredients.
Preventive maintenance and sanitation SOP’s to
prevent contamination
Proper storage temperature sufficient to prevent
pathogen growth.
Preventive maintenance and sanitation SOP’s to
prevent contamination.
Proper storage temperature suffiecient to prevent
pathogen growth.
JUSTIFICATION FOR DECISION
IF YES IN COLUMN 3
.
Temperature control to reduce a
potential risk of pathogenic growth.
What measures could be applied to
prevent, eliminate, or reduce the
hazard to an accepable level?
Yes (CCP 1B Holding
Cooler)
CONTROL POINT (CCP)?
IS THE STEP A CRITICAL
xxxvii
Cook/smoke
Storage of meat
cure
Net/stuff/
hangrack
Tumble
Inject/pump
Mix brine
Formulate
non-meat
ingredients
Storage of
non-meat
ingredients
PROCESS
STEP
P — None
C — None
Yes
P — No
P — None
B — Pathogen Reduction
C — No
B — Yes
B — Pathogen Growth
C — None
C — No
P — No
P — None
B — No
C — None
B — Microbial Spores
P — None
No
No
B — Microbial Spores
C — None
No
No
P — None
C — Excessive Nitrate
B — Pathogen Introduction
(ex. overhead contamination)
P — No
C — No
C — Nitrate
P — Foreign Materials
B — No
P — No
C — No
B — No
No
No
RESEASONABLY
LIKELY TO
OCCUR
B — Pathogen Introduction
(ex. metal)
P — Foreign Materials
C — None
B — Pathogen Introduction
P— None
C — None
B — Micobial Spores
FOOD SAFETY
HAZARD
Potential survivor and/or growth of pathogens with
improper cooking.
Proper storage temperature sufficient to prevent
pathogen growth.
Sanitation SOP’s to prevent cross-contamination.
Sanitation SOP’s to prevent cross-contamination.
Proper pump % for appropriate formulation.
Sanitation SOP’s to prevent cross-contamination.
Plant history indicated that metal contamination is
not likely to occur.
Responsible employee prepares according to
formulation.
Sanitation SOP’s to prevent cross-contamination.
Plant history indicated that metal contamination is
not likely to occur.
Responsible employee prepares according to
formulation.
Letters of guarantee are on file for all packaging
supplies and ingredients.
Letters of guarantee are on file for all packaging
supplies and ingredients.
JUSTIFICATION FOR DECISION
Temperature control to reduce a
potential risk of pathogenic growth.
.
IF YES IN COLUMN 3
What measures could be applied to
prevent, eliminate, or reduce the
hazard to an accepable level?
Yes
(CCP 3B)
Yes
(CCP 2B cured meat cooler)
CONTROL POINT (CCP)?
IS THE STEP A CRITICAL
xxxviii
Ship
Storage of
finished product
Package and
label
Fabricate
Chill/storage
PROCESS
STEP
P — No
P — Foreign Materials
B — No
B — Pathogen Growth
C — No
P — No
P — Foreign Materials
C — None
C — No
B — No
B — Pathogen Growth
C — None
P — No
P — None
B — No
B — Pathogen Contamination
C — No
P — No
P — None
C — Nitrate
C — No
C — None
(Listeria monocytogenes)
No
P — No
P— Foreign Materials
B — Pathogen Contamination
C — No
B — Yes
RESEASONABLY
LIKELY TO
OCCUR
C — None
B — Pathogen Growth
FOOD SAFETY
HAZARD
IF YES IN COLUMN 3
Container integrity.
No
Low risk, temperature abuse is unlikely to occur,
since truck temperatures are sufficient to prevent
pathogen growth.
Yes
(CCP 5B holding cooler)
No
Temperature control to reduce a
potential risk of pathogenic growth.
No
Container integrity.
Improper storage temperature can provide ambient
temperature for both pathogenic growth.
Sanitation Standard Operating Procedures are in
place to prevent contamination.
No
Potential contamination form envirnmental sources.
Pre-operational and operation sanitation can reduce
the risk of contamination from the environment and
cross-contamination between products.
Yes
(CCP 4B smoked meats cooler)
CONTROL POINT (CCP)?
IS THE STEP A CRITICAL
No
.
Temperature control to reduce a
potential risk of pathogenic growth.
What measures could be applied to
prevent, eliminate, or reduce the
hazard to an accepable level?
Container integrity.
Potential survival and/or growth of pathogens with
improper chilling. Improper storage temperature
can provide ambient temperature for both spoilage
and pathogenic growth.
JUSTIFICATION FOR DECISION
xxxix
Same as CCP1B
Same as CCP1B
Same as CCP1B
Same as CCP1B
Same as
CCP1B
CCP 4B
Holding
Cooler
The temperature of the
finished and packaged
product areas will be
taken continuously by
a computerized data
recorder with an alarm.
Same as CCP1B
Same as CCP1B
The temperature of the
smoked meat storage areas
will be taken continuously
by a computerized data
recorder with an alarm.
Same as
CCP1B
Specific corrective actions will be
recorded for each deviation from the
critical limit. Corrective actions may
include but are not limited to: holding in the oven until the temperature
is reached, recooking the product,
reworking the product, or disposing
of the product.
CCP 4B
Smoked
Meat
Cooler
Non-compliance
Report
Smokehouse Log
At the end of the cooking,
the oven operator or
designee will take and
record the internal
temperature per each
product in the oven.
The temperature will be
taken with a calibrated
thermometer.
The minimal
internal
temperature
must reach
148°F.
Non-compliance
Log
See the Corrective Action Report for
the specific actions taken to bring
the CCP under control. Corrective
actions may include but are not
limited to; Plant management will
immediately notify maintenance
personnel to repair the cooler. The
temperature of the cooler will
be brought into compliance as
soon as possible. If the increased
temperature effects product
temperature, the product will be
temporarily relocated in another
cooler or freezer, a hold may be
placed on the cooler to prevent cold
air from escaping.
CORRECTIVE ACTIONS
Bi-weekly or
as necessary a
printout of the
plant temperatures.
MONITORING
RECORDS
CCP 3B
Internal
Product
Temperature
The temperature of the raw
meat storage areas will be
taken continuously by a
computerized data recorder
with an alarm.
MONITORING
PROCEDURES &
FREQUENCIES
The temperature of the
cured meat storage areas
will be taken continuously
by a computerized data
recorder with an alarm.
The cooler
temperature
is not to
exceed 40°F
except for
periods of
defrost.
CRITICAL
LIMITS
Same as
CCP 2B
Cured Meat CCP1B
Cooler
Hazard:
Pathogen
Growth
CCP 1B
Holding
Cooler
CCP
Same as CCP1B
Same as CCP1B
Same as CCP1B
Daily review of production records
by management Visual Observations
of procedures will be conducted on a
monthly basis or as necessary. Findings will be recorded on the Monthly
Verification Log.
Same as CCP1B
Same as CCP1B
Monthly Verification Log
Thermometers will be calibrated on a Thermometer Calibration
Log
monthly basis or as necessary.
Same as CCP1B
Thermometer Calibration
Log
Thermometers. Alarms will be
checked and if necessary calibrated
on a monthly basis.
Monthly Verification Log
VERIFICATION
RECORDS
VERIFICATION PROCEDURES &
FREQUENCIES